DIAZYME PRODUCT DESCRIPTIONS INNOVATIONS IN CLINICAL DIAGNOSTICS

Transcription

1 DIAZYME PRODUCT DESCRIPTIONS DESCRIPTIONS PRODUCT 2 15 INNOVATIONS IN CLINICAL DIAGNOSTICS

2 About Diazyme Diazyme Laboratories is a Division of General Atomics located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Diazyme is a cgmp and ISO certified medical device manufacturer. Diazyme s products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes and electrolytes. Mission Statement Our mission is to improve the quality of healthcare by providing innovative products in clinical diagnostics. Contact Information Diazyme Laboratories Gregg Court Poway, CA U.S.A. Tel: (888) DIAZYME (858) Fax: (858) sales@diazyme.com Diazyme Europe GmbH Zum Windkanal Dresden, Deutschland Tel: +49 (0) Fax: +49 (0) sales@diazyme.de

3 Contents Page List 4 Clinical Chemistry Reagents 6 Instrument Specific 28 Smart Instruments 33 Ordering Information 35 (858) (888)-DIAZYME (Toll Free US only)

4 DIAZYME List Clinical Chemistry Reagents SEPSIS MARKERS DZ558A Procalcitonin (PCT) Assay USA: For Research Use Only; EU: 6 CARDIOVASCULAR MARKERS DZ141A Apolipoprotein A-I Assay (Immunoturbidimetric) (Dual Vial ) 9 DZ142A Apolipoprotein B Assay (Immunoturbidimetric) (Dual Vial ) 9 DZ129A HDL-Cholesterol Assay (PVS\PEGME Coupled) (Dual Vial ) 8 DZ128A LDL-Cholesterol Assay (PVS\PEGME Coupled) (Dual Vial ) 9 DZ568A Homocysteine Enzymatic Assay (Three Vial ) 6 DZ568B Homocysteine Enzymatic Assay (Dual Vial ) 7 DZ568B Homocysteine POC Test Kit 33 DZ131A Lipoprotein (a) [Lp(a)] Assay (Immunoturbidimetric) (Dual Vial ) 7 DZ145A Cardiac Troponin I Assay (Immunoturbidimetric) (Dual Vial ) USA: For Research Use Only; EU: 10 DZ147A Myoglobin Assay (Dual Vial ) 10 DIABETIC MARKERS DZ136A Albumin Assay (BCG) (Single Vial ) 12 DZ168A Direct Enzymatic HbA1c Assay, Single Channel (Liquid stable) 11 DZ168B HbA1c for SMART Analyzer 33 DZ112B Glycated Serum Protein (Glycated Albumin) Assay (Dual Vial ) 12 DZ865A Insulin Assay 510(k) Exempt; 13 DZ187A Retinol Binding Protein (RBP) Assay USA: For Research Use Only; EU: 13 RENAL AND PANCREATIC MARKERS DZ072B Creatinine Assay (Enzymatic) (Dual Vial ) 14 DZ133C Cystatin C Assay (Immunoturbidimetric) (Dual Vial ) 15 DZ133D Cystatin C POC Test Kit 33 DZ132A Lipase Assay (Dual Vial ) 510(k) Exempt; 15 DZ062A N-acetyl-b-D-glucosaminidase (NAG) Assay (Three Vial ) USA: For Research Use Only; EU: 16 ANEMIA MARKER DZ526A Ferritin Assay (Immunoturbidimetric) (Dual Vial ) 16 LIVER MARKERS DZ123A 5'- Nucleotidase Assay (Dual Vial ) 510(k) Exempt; 17 DZ117A Adenosine Deaminase (ADA) Assay (Dual Vial ) USA: For Research Use Only; EU: 17 DZ082B a-l-fucosidase (AFU) Assay (Single Vial ) USA: For Research Use Only; EU: 19 DZ151A Direct Bilirubin Assay (Vanadate) (Dual Vial ) 20 DZ150A Total Bilirubin Assay (Vanadate) (Dual Vial ) 20 DZ042A Total Bile Acids Assay (Enzyme Cycling Method) (Dual Vial ) 18 DZ092A Total Bile Acids Assay (NBT Method) (Dual Vial, Powder & Diluent) USA: For Research Use Only 18 DZ760A Cholylglycine (CG) Assay (Immunoturbidimetric) (Dual Vial ) USA: For Research Use Only 19 Page (858)

5 DIAZYME List Clinical Chemistry Reagents (Continued) ELECTROLYTES DZ122A Carbon Dioxide (CO 2 ) Assay (Enzymatic 405 nm) (Single Vial ) 22 DZ116B Lithium Assay (Enzymatic) (Dual Vial ) 22 DZ113C Potassium Assay (Enzymatic) (Dual Vial ) 21 DZ114B Sodium Assay (Enzymatic) (Dual Vial ) 21 INFLAMMATORY MARKERS DZ135A hscrp Assay (Immunoturbidimetric) (Dual Vial ) 23 DZ135B hscrp POC Test Kit 33 DZ178C Myeloperoxidase (MPO) Immunoassay (Dual Vial ) USA: For Research Use Only; EU: 23 COAGULATION DZ179A D-Dimer Assay (Dual Vial ) 24 CANCER MARKERS DZ869A α-fetoprotein (AFP) Assay USA: For Research Use Only; EU: 24 VITAMIN MARKERS DZ688B 25-Hydroxy Vitamin D EIA Kit 25 DZ688C Vitamin D Assay for Clinical Chemistry Analyzers 26 Page *Diazyme s are 510(k) Cleared Unless Specified 5 (888)-DIAZYME (Toll Free US only)

6 SEPSIS MARKER Procalcitonin (PCT) Assay USA: For Research Use Only EU: Features Diazyme s PCT is a dual liquid stable reagent system which provides reliable results. The method requires only 15 μl of sample, completed in less than 10 minutes, and has excellent correlation with existing commercial products with R 2 of , a slope of and a y intercept of The assay has within-run precision values of less than 7.2%. Diazyme s PCT Assay is based on a latex enhanced immunoturbidimetric assay. PCT proteins in the sample bind to the specific anti-pct antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of PCT in the sample. The instrument calculates the PCT concentration of a sample by interpolation of the obtained signal of a 6-point calibration curve. Diazyme's Procalcitonin Assay is for the quantitative determination of PCT in serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. Kit (180 Tests) DZ558A-K DZ558A-CAL DZ558A-CON R1: 1 x 44 ml R2: 1 x 14 ml 2 (5 x 1 ml) vial 2 x 3 ml vial Latex Enhanced Immunoturbidimetric Assay, CARDIOVASCULAR MARKERS Homocysteine Enzymatic Assay 510(k) Cleared Three Vial Format Features The Diazyme Enzymatic Homocysteine (Hcy) Assay reagent is a liquid stable system, which provides a fast, accurate cost effective alternative to cumbersome and expensive immunochemical methods. A choice of convenient instrument specific packaging options eliminate reagent transfer for Roche TM Hitachi, Siemens Dimension, and Beckman Synchron CX, LX and DXC analyzers. Accurate and reliable, the assay features excellent correlation with HPLC and Immunochemical methods with a linear range of 3-50 µmole/l and intra and inter %CV values of < 5.9%. The assay has no significant interference from lipemic and hemolytic substances and eliminates the carry-over interference with iron or lipase reagents that can occur with other methods. More significantly, the assay is not interfered by the endogenous cystathionine and therefore can be used with confidence in patients with renal disease. The Diazyme Hcy Enzymatic Assay is based on a novel assay principle that assesses the co-substrate conversion product. In the assay, oxidized Hcy is first reduced to free Hcy which then reacts with a co-substrate, SAM, catalyzed by a homocysteine S-methyltransferase. The co-substrate conversion product is amplified by coupled enzymatic cycling reactions. The thcy level in the sample is directly proportional to the amount of NADH conversion to NAD+ (ΔA 340nm). R1: 240 µl Sample: 18 µl R3: 25 µl R2: 38 µl 37 o C nm A1 5 min 7 min 10 min A2 *Based on Hitachi 917 The Diazyme Homocysteine Enzymatic A ssay kit is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Kit (190 Tests) DZ568A-K DZ568A-CA5 DZ568A-CON R1: 1 x 54 ml R2: 1 x 11 ml R3: 1 x 8 ml 5 x 3 ml vial 4 x 3 ml vial Enzyme Cycling, (858)

7 CARDIOVASCULAR MARKERS Homocysteine Enzymatic Assay 510(k) Cleared Dual Vial Format Features Diazyme s Enzymatic Homocysteine (Hcy) Assay is a convenient dual vial liquid stable assay ideal for analyzers which require two part reagent systems. The assay provides a fast, accurate cost effective alternative to cumbersome and expensive immunochemical methods. The assay is offered with convenient instrument specific packaging options which eliminate reagent transfer for Beckman AU (400/600/640/680) analyzers. Accurate and reliable, the assay features excellent correlation with HPLC and immunochemical methods with a linear range of 3-50 µmol/l and intra and inter %CV values of < 7.5%. The assay has no significant interference from lipemic and hemolytic substances and eliminates the carry-over interference with iron or lipase reagents that can occur with other methods. More significantly, the assay is not interfered by the endogenous cystathionine and therefore can be used with confidence in patients with renal disease. In Diazyme's Hcy Assay, oxidized Hcy is first reduced to free Hcy which then reacts with a co-substrate, S-adenosylmethionine (SAM) catalyzed by a Hcy S-methyltransferase to form methionine (the Hcy conversion product of Hcy) and S-adenosylhomocysteine (SAH, the co-substrate conversion product). SAH is assessed by coupled enzyme reactions including SAH hydrolase, adenosine (Ado) deaminase and glutamate dehrogenase, where-in SAH is hydrolyzed into adenosine (Ado) and Hcy by SAH hydrolase. The formed Hcy that is originated from the co-substrate SAM is cycled into the Hcy conversion reaction by Hcy S-methyltransferase. The formed Ado is immediately hydrolyzed into inosine and ammonia. In the last step, the enzyme glutamate dehydrogenase (GLDH) catalyzes the reaction of ammonia with 2-oxoglutarate and NADH to form NAD+. R1: 240 µl Sample: 13 µl R2: 65 µl 0 37 o C 340 nm min A1 A2 The Diazyme Homocysteine 2 Reagent Enzymatic Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Kit (190 Tests) DZ568B-K DZ568A-CA5 DZ568A-CON R1: 1 x 52 ml R2: 1 x 15 ml 5 x 3 ml vial 4 x 3 ml vial Enzyme Cycling, Lipoprotein (a) [Lp(a)] Assay 510(k) Cleared Features Diazyme s Lp(a) is a dual liquid stable reagent system which provides reliable results and is offered with time saving instrument specific packaging options which eliminate reagent transfer and increase operator efficiency. Instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC. The method requires only 6 µl of serum sample completed in less than 10 minutes and has excellent correlation with existing commercial products with R 2 of 0.998, slope of 0.99, and y intercept of The assay has intra precision values of less than 2.6%. Diazyme's Lp(a) Assay is based on a latex enhanced immunoturbidimetric method. Lp(a) in the sample binds to the specific anti-lp(a) antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lp(a) in the sample. The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA) on clinical chemistry systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only. Kit (300 Tests) Alternative Alternative DZ131A-K DZ131A-CAL DZ131A-CON DZ138A-CON DZ131B-CAL DZ131B-CON R1: 1 x 60 ml R2: 1 x 20 ml 5 x 1 ml vial 2 x 1 ml vial 3 x 3 ml vial 5 x 1 ml vial 2 x 1 ml vial Latex Enhanced Immunoturbidimetric Assay, 7 (888)-DIAZYME (Toll Free US only)

8 CARDIOVASCULAR MARKERS HDL-Cholesterol Assay 510(k) Cleared Features Diazyme s HDL-Cholesterol Assay is a direct dual liquid stable reagent system. Convenient instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC. The assay utilizes Diazyme s proprietary PVS\PEGME coupled technology which provides outstanding performance. The assay features a linear range of 1.06 to mg/dl, intra and inter %CV values < 5 % and less than 10% interference from triglycerides to 1000 mg/dl, ascorbic acid to10 mmol/l, bilirubin to 40 mg/dl, bilirubin conjugate to 30 mg/dl, hemoglobin to 1000 mg/dl. The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol-methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER). The enzymes selectivity react with HDL to produce H 2 O 2 which is detected through a Trinder reaction. The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. Kit (1120 Tests) DZ129A-K DZ130A-CAL DZ138A-CON R1: 4 x 70 ml R2: 2 x 50 ml 1 x 1 ml vial 3 x 3 ml vial Modified PVS/PEGME/, LDL-Cholesterol Assay 510(k) Cleared Features Diazyme s LDL-Cholesterol Assay is a direct dual liquid stable reagent system. Reagent transfer is eliminated for most chemistry systems with a choice of convenient instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC. The assay utilizes Diazyme s proprietary PVS\PEGME coupled technology which provides outstanding performance. The assay features a linear range of up to 250 mg/dl, intra and inter %CV values < 5.0 % and less than 10% interference from triglycerides to 1000 mg/dl, ascorbic acid to 10 mmol/l, bilirubin to 40 mg/ dl, bilirubin conjugate to 30 mg/dl, hemoglobin to 1000 mg/dl. The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL,VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H 2 O 2 which is quantified by the Trinder reaction. The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy. Kit (1120 Tests) DZ128A-K DZ130A-CAL DZ138A-CON R1: 4 x 70 ml R2: 2 x 50 ml 1 x 1 ml vial 3 x 3 ml vial Modified PVS/PEGME/, (858)

9 CARDIOVASCULAR MARKERS Apolipoprotein A-I (Apo A-I) Assay 510(k) Cleared Features Diazyme s Apo A-I Assay kit has a linear range of mg/dl and good correlation with an existing FDA approved product with R 2 values >0.98. The Diazyme Apo A-I Assay is not interfered by the following substances at the indicated concentrations: triglycerides at 1000 mg/dl, ascorbic acid at 10 µm, bilirubin at 40 mg/dl, bilirubin conjugate at 40 mg/dl, and hemoglobin at 1000 mg/dl. This method is based on the reaction of a sample containing human Apo A-I and a specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340 nm. By constructing a standard curve from the absorbance of standards the concentration of Apo A-I in the sample can be determined. The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of Apolipoprotein A-I (Apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro diagnostic use. Kit (1120 Tests) DZ141A-K DZ141A-CAL DZ138A-CON R1: 4 x 70 ml R2: 2 x 50 ml 1 x 1 ml vial 3 x 3 ml vial Immunoturbidimetric, Apolipoprotein B (Apo B) Assay 510(k) Cleared Features Diazyme s Apo B Assay has a linear range of mg/dl with good correlation with existing FDA approved product with R 2 values >0.99. The Diazyme Apo B Assay is not interfered by the following substances at the indicated concentrations: triglycerides at 1000 mg/dl, ascorbic acid at 10 µm, bilirubin at 40 mg/dl, bilirubin conjugate at 40 mg/dl, and hemoglobin at 1000 mg/dl. This method is based on the reaction of a sample containing human Apo B and a specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340 nm. By constructing a standard curve from the absorbance of standards the concentration of Apo B in the samples can be determined. The Diazyme Apolipoprotein B Assay is intended for the quantitative in vitro determination of Apolipoprotein B (Apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro diagnostic use. Kit (1120 Tests) DZ142A-K DZ141A-CAL DZ138A-CON R1: 4 x 70 ml R2: 2 x 50 ml 1 x 1 ml vial 3 x 3 ml vial Immunoturbidimetric, 9 (888)-DIAZYME (Toll Free US only)

10 CARDIOVASCULAR MARKERS Cardiac Troponin I Assay USA: For Research Use Only EU: Features Diazyme s Cardiac Troponin I Assay is a highly sensitive liquid stable latex enhanced immunoturbidimetric test kit, designed to work on most open clinical chemistry analyzers. Diazyme s Troponin I Assay provides rapid reliable results at a low reagent cost. Diazyme Cardiac Troponin I Assay is convenient, fast and an accurate alternative to more expensive methods that require a dedicated immunochemistry instrument. The assay offers reliable results across the entirely clinical important reportable range from ng/ml troponin I with excellent precision CV% of <2.8% at 2.85 mg/ml. Diazyme s Cardiac Troponin I Assay is based on a latex enhanced immunoturbidimetric assay. Cardiac troponin I in the sample binds to the specific anti-troponin I antibodies, which are coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of troponin I in the sample. The Diazyme Cardiac Troponin I Assay is for the determination of cardiac troponin I in serum or plasma by latex enhanced immunoturbidimetric method. For Research Use Only in USA. Kit (180 Tests) DZ145A-K DZ145A-CAL DZ145A-CON R1: 1 x 40 ml R2: 1 x 10 ml 6 x 1 ml vial 2 x 1 ml vial Latex Enhanced Immunoturbidimetric Assay, Myoglobin Assay 510(k) Cleared Features Diazyme s Myoglobin Assay is based on latex enhanced immunoturbidimetric method. The assay is formulated in a convenient dual liquid stable format, and it is highly cost effective. Myoglobin is a cardiac biomarker that helps diagnose or rule out heart attacks. An increase in myoglobin is detectable sooner than troponin I, but is not as specific for heart damage and it will not stay elevated as long as troponin I. Although a negative myoglobin result effectively rules out a heart attack, a positive result must be confirmed by additional testing. Diazyme s Myoglobin Assay is linear from ng/ml with a correlation coefficient value of , slope of and y intercept of The common substances of triglyceride, ascorbic acid, bilirubin, conjugated bilirubin, hemoglobin, rheumatoid factor, heparin and additional substances of drug interference showed no significant interference. Diazyme s Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined from a calibration curve prepared from calibrators of known concentrations. The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use. Kit (200 Tests) DZ147A-K DZ147A-CAL DZ147A-CON R1: 1 x 46 ml R2: 1 x 13 ml 5 x 1 ml vial 2 x 1 ml vial Latex Enhanced Immunoturbidimetric, (858)

11 DIABETIC MARKERS Direct Enzymatic HbA1C Assay IFCC Certified 510(k) Cleared Features Diazyme s IFCC certified Direct Enzymatic HbA1c Assay has no interference from hemoglobin variants including HbC, HbS, HbE, and caramylated acetylated Hb or labile HbA1c. This unique freedom from interference combined with unparalleled precision (intra and inter % CV values less than 2.6%) means that Diazyme s Direct Enzymatic HbA1c Assay provides unique performance advantages over conventional immunoassay and chromatography methods. Diazyme s patented enzymatic method measures HbA1c directly using only a single instrument channel and completely eliminates the latex particles cuvette contamination often seen in HbA1c immunoassay methods. This reduces instrument maintenance requirements. Diazyme s Direct Enzymatic HbA1c can be used on most automated chemistry analyzers and reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC analyzers. The assay correlates well with conventional methods such as the Tosoh HPLC and Roche Tina-Quant methods. Direct Enzymatic HbA1c Assay is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion with Bacillus sp protease. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as substrates for specific recombinant fructosyl valine oxidase (FVO) enzyme, produced in E. coli. The recombinant FVO specifically cleaves N-terminal valines and produces hydrogen peroxide. This, in turn, is measured using a horseradish peroxidase (POD) catalyzed reaction and a suitable chromogen. No separate measurement for total hemoglobin (Hb) is needed in this Direct Enzymatic HbA1c Assay. The HbA1c concentration is expressed directly as %HbA1c by use of a suitable calibration curve in which the calibrators have values for each level in %HbA1c. Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbA1c) reagents are intended for use in the quantitative determination of stable HbA1c in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long term diabetic control. For in vitro diagnostics use only. Kit (90 Tests) DZ168A-K DZ168A-CAL DZ168A-CON Lysis Buffer: 1 x 30 ml R1a: 1 x 16.8 ml R1b: 1 x 7.2 ml R2: 1 x 10 ml 2 x 0.5 ml vial 2 x 0.5 ml vial Enzymatic, endpoint, 11 (888)-DIAZYME (Toll Free US only)

12 DIABETIC MARKERS Glycated Serum Protein Assay 510(k) Cleared Features Diazyme s enzymatic assay for glycated serum protein provides improved specificity and reliability compared to conventional NBT-based methods. The assay is highly precise with a total CV 1.3%. The assay offers extensive linearity from 21 µmol/l to 1354 µmol/l. The assay has no significant interference from: ascorbic acid (5 mg /dl); bilirubin (7.5 mg/dl); bilirubin conjugated (5 mg/dl); glucose (2400 mg/dl; hemoglobin (200 mg/dl); triglycerides (2000 mg/dl); and uric acid (35 mg/dl). Diazyme s Glycated Serum Protein Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosaminase, a microorganism originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield PF or amino acids, glucosone and H 2 O 2. The H 2 O 2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at nm is proportional to the concentration of glycated serum proteins. Diazyme Glycated Serum Protein Assay in conjunction with Diazyme Glycated Serum Protein single calibrator is intended for the quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only. Kit (225 Tests) DZ112B-K DZ112B-CAL DZ112B-CON R1: 1 x 45 ml R2: 1 x 14 ml 2 x 1 ml vial 2 x 1 ml vial Colorimetric, endpoint, Albumin Assay 510(k) Cleared Features Diazyme s Albumin Assay has a linearity of g/dl with a correlation coefficient value of slope of 1.01 and a y-intercept of 0.23 g/dl., The common interfering substances of Hemoglobin, Bilirubin and Lipemia showed no significant interference. When stored at 2-8 C, the reagent is stable until the expiration date. The Diazyme Albumin Assay is based on the dye-binding properties of serum albumin with bromcresol green. The absorbance of BCG at 630 nm increases with binding to albumin and is proportional to the albumin concentration present. Diazyme Albumin Assay is intended for the quantitative determination of albumin in human serum. For in vitro diagnostics use only. Kit (200 Tests) DZ136A-K DZ136A-CAL DZ136A-CON R1: 1 x 48.5 ml 1 x 5 ml vial 2 x 5 ml vial Bromcresol Green (BCG) (858)

13 DIABETIC MARKERS Insulin Assay 510(k) Exempt Features Diazyme s Insulin Assay is a dual liquid stable reagent system which provides reliable results. The method requires only 12 μlof sample, completed in less than 10 minutes, and has excellent correlation within-run existing commercial products with R 2 of , a slope of and a y intercept of The assay has within-run precision values lower than 1.19% and a between-run precision value of 4.34%. Latex particles coated with antibody specific to human insulin form immune complexes in the presence of insulin from the sample. The immune complexes cause an increase in light scattering that is pro-portional to the concentration of insulin in the serum or plasma sample. The light scattering is measured by reading turbidity at 600 nm primary, 800 nm secondary. The sample insulin concentration is determined versus insulin calibrators of known concentrations. For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay. For in vitro diagnostic use only. Kit (100 Tests) DZ865A-K DZ865A-CAL DZ865A-CON R1: 1 x 13.5 ml R2: 1 x 5 ml 5 x 0.5 ml vial 3 x 5 ml vial Latex Enhanced Immunoturbidimetric Assay, Retinol Binding Protein (RBP) Assay USA: For Research Use Only EU: Features Diazyme s Retinol Binding Protein (RBP) is a dual liquid stable reagent system which provides reliable results. The method requires only 3 μl of sample, completed in less than 10 minutes, and has excellent correlation with existing commercial products with R 2 of , a slope of and a y intercept of The assay has within-run precision values of less than 1.2% and a total precision value less than 3.2%. Diazyme s RBP Assay is based on a latex enhanced immunoturbidimetric assay. RBP in the sample bind to the specific anti-rbp antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of RBP in the sample. The instrument calculates the RBP concentration of a sample by interpolation of the obtained signal of a 5-point calibration curve. The Retinol Binding Protein (RBP) Assay is for the quantitative determination of RBP in samples. Kit (240 Tests) DZ187A-K DZ187A-CAL DZ187A-CON R1: 1 x 45 ml R2: 1 x 15 ml 5 x 1 ml 2 x 1 ml Latex Enhanced Immunoturbidimetric Assay, 13 (888)-DIAZYME (Toll Free US only)

14 RENAL AND PANCREATIC MARKERS Enzymatic Creatinine Assay 510(k) Cleared Features Diazyme s Creatinine Liquid Reagents Assay offers significant advantages compared to the conventional Jaffe method for Creatinine which is caustic (picric acid) and can stain analyzer tubing and cuvettes. Diazyme s enzymatic method is non-caustic, non-staining and has no costly hazardous shipping requirements. Unlike the Jaffe method Diazyme s enzymatic assay shows that the following substances normally present in serum produced less than 10% deviation at the listed concentrations: Triglyceride at 1000 mg/dl, Ascorbic Acid at 10 mm, Bilirubin at 40 mg/dl, Bilirubin Conjugate at 30 mg/dl, Hemoglobin at 500 mg/dl. The following substances normally present in urine produced less than 10% deviation at the listed concentrations: Triglycerides at 1000 mg/dl, Ascorbic Acid at 10 mm, Bilirubin at 40 mg/dl, Bilirubin Conjugate at 40 mg/dl, Hemoglobin at 1000 mg/dl. Packaged for optimal operator convenience, reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX. Diazyme s Creatinine Liquid Reagents Assay is a quick, easy to use enzymatic procedure applicable to routine laboratory instrumentation. Enzymatic methodology is a better clinical choice for the accurate measurement of creatinine, especially for neonates, pediatrics, and hematology units. The enzymatic assay for creatinine involves a series of coupled enzymatic reactions including creatininase enzymatic conversion of creatinine into the product creatine which itself is converted to sarcosine by creatine amidinohydrolase (creatinase), followed by oxidation of sarcosine by sarcosine oxidase (SOD) producing hydrogen peroxide. In the presence of peroxidase (POD) the hydrogen peroxide is quantified at 550 nm by the formation of a colored dye. Any endogenous creatine present in the sample is removed by creatinase and sarcosine oxidase during pre-incubation. Diazyme s Creatinine Liquid Reagents Assay, in conjunction with Diazyme s Creatinine, is intended for the quantitative determination of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. For in vitro diagnostic use only. Kit (200 Tests) DZ072B-K DZ072B-CAL DZ072B-CON R1: 1 x 60 ml R2: 1 x 20 ml Cal: 1 x 1 ml vial ( Included) 1 x 1 ml vial 1 x 1 ml vial Colorimetric, Endpoint, (858)

15 RENAL AND PANCREATIC MARKERS Cystatin C Assay 510(k) Cleared Features Diazyme s Cystatin C Assay is a convenient cost effective dual liquid stable latex enhanced immunoturbidimetric method. This critically important emerging marker aids in the early detection and diagnosis of renal disease. The assay is highly sensitive with a sensitivity of mg/dl, and an extended linear range from mg/dl. The Diazyme method has an excellent correlation with existing commercially available products and is highly precise with intra and inter-assay precision CV% of <5.0%. Packaged for optimal operator convenience, reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, DXC and Dimension/Expand. Diazyme s Cystatin C Assay is based on a latex enhanced immunoturbidimetric assay. Cystatin C in the sample binds to the specific anti-cystatin C antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of cystatin C in the sample. The instrument calculates the cystatin C concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve. The Diazyme Cystatin C Assay is an in vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro diagnostic use only. Kit (360 Tests) DZ133C-K DZ133C-CAL DZ133C-CON R1: 1 x 100 ml R2: 1 x 20 ml 5 x 1 ml vial 2 x 1 ml vial Latex Enhanced Immunoturbidimetric Assay, Lipase Assay 510(k) Exempt Features Diazyme s Lipase Assay provides an extended linear range up to 250 U/L with virtually no interferences from triglyceride 300 mg/dl, hemoglobin 150 mg/dl, and bilirubin up to 20 mg/dl. Diazyme s Lipase Assay has excellent inter-assay and intra-assay precision. The assay has an excellent correlation to Beckman lipase reagent with R² = The method for the determination of lipase is based on the cleavage of specific chromogenic lipase substrate 1,2-O-dilaurylrac-glycero-3-glutaric acid-(6'methyl-resorufin)-ester emulsified in stabilized micro-particles. In the presence of specific activators of pancreatic lipase as colipase, calcium ions and bile acids, the substrate is converted to 1,2-O-dilauryl-rac-glycerol and glutaric acid-6'-methylresorufinester which decomposes spontaneously to glutaric acid and methylresorufin. The increase of absorbance at 580 nm, due to methylresorufin formation, is proportional to the activity of lipase in the sample. The Diazyme Lipase assay in conjunction with lipase assay calibrator set is intended for the in vitro quantitative determination of lipase in serum or plasma. Kit (300 Tests) DZ132A-K DZ132A-CAL DZ132A-CON R1: 2 x 50 ml R1: 2 x 11 ml 1 x 1 ml vial 2 x 5 ml vial Colorimetric, 15 (888)-DIAZYME (Toll Free US only)

16 RENAL AND PANCREATIC MARKERS N-Acetyl-β-D-glucosaminidase (NAG) Assay USA: For Research Use Only EU: Features Diazyme s N-Acetyl-β-D-glucosaminidase (NAG) Assay is ready-to-use for manual methods and adaptable for analyzers. The assay is specific for NAG and has excellent sensitivity with a linear range up to 200 IU/L² and excellent precision with a CV% of <5%. There is no significant interference from hemoglobin or albumin. Interference from bilirubin occurs only at levels higher than 5 mg/dl. The reagents of the assay kit are in stable liquid formulation that allows ease of use coupled with enhanced performance characteristics. NAG hydrolyses 2-methoxy-4-(2 nitrovinyl)-phenyl 2-acetamido-2-deoxy-β-D-glucopyranoside (MNP-GlcNAc) to 2-methoxy-4-(2 -nitrovinyl)-phenol product. The product formation is detected by development of color at 505nm upon addition of an alkaline buffer. The N-Acetyl-β-D-glucosaminidase (NAG) assay kit is for determination of NAG in urine samples. For Research Use Only in the USA. Kit (540 Tests) DZ062A-K DZ062A-CAL DZ062A-CON R1: 1 x 75 ml R2: 1 x 15 ml R3: 1 x 30 ml Cal: 1 x 2 ml vial ( Included & Packaged Separately) 1 x 2 ml vial 2 x 2 ml vial Colorimetric, Endpoint, ANEMIA MARKER Ferritin Assay 510(k) Cleared Features Diazyme s Ferritin Assay is a dual liquid stable reagent system. The method requires only 10 μl of sample, completed in less than 10 minutes, and has excellent correlation with existing commercial products with R 2 of , a slope of and a y intercept of The assay has within-run precision values of less than 4.1% and a total precision value less than 9.5%. The Diazyme Ferritin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between Ferritin in a sample and anti-ferritin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (560 nm), with the magnitude of the change being proportional to the quantity of Ferritin in the sample. The actual concentration is then determined from a calibration curve prepared from calibrators of known concentrations. The Diazyme Ferritin Assay is for the quantitative determination of ferritin in serum and plasma samples. For in vitro diagnostic use only Kit (100 Tests) DZ526A-K DZ526A-CAL DZ526A-CON R1: 1 x 27 ml R2: 1 x 8.5 ml 4 x 1 ml vial 2 x 1 ml vial Latex Enhanced Immunoturbidimetric Assay, (858)

17 LIVER MARKERS 5'-Nucleotidase (5'NT) Assay 510(k) Exempt Features Diazyme s 5'-Nucleotidase Assay is linear from U/L (R² >0.99) with intra-assay CV% of <2% and an inter-assay CV% of 4%. 5'-Nucleotidase assay is not affected by interfering substances such as serum bilirubin up to 40 mg/dl, hemoglobin up to 500 mg/dl, triglycerides up to 1250 mg/dl, ascorbic acid up to 20 mg/dl, and alkaline phosphatase up to 1250 U/L. The 5'-NT assay is based on the enzymatic hydrolysis of 5'-monophosphate (5'-IMP) to form inosine which is converted to hypoxanthine by purine nucleoside phosphorylase (PNP). Hypoxanthine is then converted to uric acid and hydrogen peroxide (H 2 O 2 ) by xanthine oxidase (XOD). H 2 O 2 is further reacted with N-Ethyl- N-(2-hydroxy-3-sulfopropyl)-3-methylaniline (EHSPT) and 4- aminoantipyrine (4-AA) in the presence of peroxidase (POD) to generate quinone dye which is monitored in a kinetic manner. The 5'-Nucleotidase (5'-NT) assay kit is for the determination of 5'-NT activity in human serum samples. Kit (250 Tests) DZ123A-K DZ123A-CAL DZ123A-CON R1: 1 x 50 ml R2: 1 x 25 ml Cal: 1 x 1 ml vial ( Included & Packaged Separately) 1 x 1 ml vial 2 x 1 ml vial Colormetric/Kinetic, Adenosine Deaminase (ADA) Assay USA: For Research Use Only EU: Features The assay is linear from U/L and has precisions of Intra assay %CV < 4.5% and Inter assay %CV < 5.0%.The assay is ready-to-use for both manual method and automated chemistry analyzers (Kinetic). The assay is specific for ADA and has no detectable reaction with other nucleosides and is not affected by serum bilirubin up to 30 mg/dl, hemoglobin up to 200 mg/dl, triglycerides up to 750 mg/dl, or ascorbic acid up to 4 mg/dl. The assay is based on H 2 O 2 detection, which is more sensitive and reliable than the method detecting ammonia production. Diazyme s ADA Assay is based on the enzymatic deamination of adenosine to inosine which is converted to hypoxanthine by purine nucleoside phosphorylase (PNP). Hypoxanthine is then converted to uric acid and hydrogen peroxide (H 2 O 2 ) by xanthine oxidase (XOD). H 2 O 2 is further reacted with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline (EHSPT) and 4-aminoantipyrine (4-AA) in the presence of peroxidase (POD) to generate quinone dye which is monitored in a kinetic manner. The entire enzymatic reaction scheme is shown below. Adenosine Deaminase (ADA) Assay kit is for determination of ADA activity in serum and plasma samples. Kit (250 Tests) DZ117A-K DZ117A-CAL DZ117A-CON R1: 1 x 50 ml R2: 1 x 25 ml Cal: 1 x 1 ml vial ( Included & Packaged Separately) 1 x 1 ml vial 2 x 1 ml vial Colorimetric/Kinetic, 17 (888)-DIAZYME (Toll Free US only)

18 LIVER MARKERS Total Bile Acids (Enzyme Cycling Method) Assay 510(k) Cleared Features The Diazyme Total Bile Acids Assay is a liquid stable system, ready to use for both manual methods and is adaptable for many automated chemistry analyzers. The assay has excellent sensitivity with a linear range from µm. Diazyme s unique enzyme cycling method amplifies signal for accurate and fast measurement using a small sample up to 50% less than conventional NBT methods making it an excellent choice. The assay has excellent precision with Intra-Assay Precision CV% of <4% and Inter-Assay Precision CV% of <3%. The following substances normally present in serum produced less than 10% deviation at the listed concentrations: Triglycerides at 750 mg/dl, Ascorbic acid at 50 mg/dl, Bilirubin at 50 mg/dl and Hemoglobin at 500 mg/dl. Packaged for optimal operator convenience reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, and DXC. The reagents of the assay kit are in a stable liquid formulation that allows for ease of use coupled with enhanced performance characteristics. In the presence of Thio-NAD, the enzyme 3-α-hydroxysteroid dehydrogenase (3- α-hsd) converts bile acids to 3-keto steroids and Thio-NADH. The reaction is reversible and 3-α-HSD can convert 3-keto steroids and Thio- NADH to bile acids and Thio-NAD. In the presence of excess NADH, the enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 405 nm. Diazyme Total Bile Acids Assay Kit is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum. Total bile acids are metabolized in the liver and serve as a marker for normal and abnormal liver function. Serum total bile acids are increased in patients with liver disease. Kit (400 Tests) DZ042A-K DZ042A-CAL DZ042A-C1V DZ042A-CON R1: 2 x 60 ml R2: 2 x 20 ml Cal: 1 x 2 ml vial ( Included) 1 x 2 ml vial 1 x 1 ml vial 2 x 1 ml vial Enzymatic, Endpoint, Total Bile Acids (NBT Method) Assay For Research Use Only in USA Features The Total Bile Acid (NBT Method) Assay is linear up to a concentration of 180 µm and has a correlation coefficient of The following substances normally present in serum produced less than 10% deviation at the listed concentrations: Triglycerides at 750 mg/dl, Ascorbic acid at 50 mg/dl, Bilirubin at 50 mg/dl and Hemoglobin at 500 mg/dl. In the presence of NAD, the enzyme 3- hydroxysteroid dehydro-genase (3- HSD) converts bile acids to 3-keto steroids and NADH. The NADH formed reacts with nitrotetrazolium blue (NBT) to form a formazan dye in the presence of diaphorase enzyme. The dye formation is monitored by measuring absorbance at 540nm and is directly proportional to the bile acids concentration in the serum sample. The assay kit is for determination of serum total bile acids (TBA). For research use only in USA. Kit (600 Tests) DZ092A-K DZ092A-CAL DZ092A-CON R1 (diluent): 1 x 105 ml R2: 1 x 20 ml R3: 10 x 10 ml Cal: 1 x 2 ml vial ( Included) 1 x 2 ml 1 x 1 ml Enzymatic, Endpoint/Powder, (858)

19 LIVER MARKERS Cholylglycine (CG) Assay USA: For Research Use Only Features The Diazyme Cholylglycine (CG) Assay is a dual vial liquid stable system, which provides reliable results. The assay has excellent sensitivity with a linear range up to 20 µg/ml. Diazyme s unique latex enhanced immunoturbidimetric method has excellent Within-Run precision CV% of 0.024%. The limit of detection of the Diazyme CG assay is 0.5 μg/ml. The Deming regression results showed a correlation of R 2 of , a slope of , and a y-intercept of Diazyme s CG assay is a homogenous enzyme immunoassay based on competition between cholylglycine in a sample and cholylglycine-g6pdh (Glucose-6-Phosphate Dehydrogenase) conjugate for specific antibody binding sites. Binding of the antibody to the analyte enzyme complex partially inhibits activity of the G6PDH. Cholylglycine presented in a sample binds to the anti-cg antibody and displaces enzyme cholylglycine conjugate resulting in increase of G6PDH activity, measured spectrophotometrically at 340 nm. The amount of cholylglycine presented in a sample is proportional to the increase of the absorbance at 340 nm. The instrument calculates the cholylglycine concentration of a patient specimen by interpolation of the obtained signal, relative to a 6-point calibration curve. The Diazyme Cholylglycine (CG) assay is for the quantitative determination of Cholylglycine in human serum on automated clinical chemistry analyzers. Measurement of Cholylglycine is of use for the detection and evaluation of liver diseases and hepatic damage. For Research Use Only in USA. Kit (115 Tests) DZ760A-K DZ760A-CAL DZ760A-CON R1: 1 x 25.5 ml R2: 1 x 7.9 ml Cal: 6 x 1 ml vial ( Included & Packaged Separately) 6 x 1 ml vial 2 x 3 ml vial Latex Enhanced Immunoturbidimetric Assay, α-l-fucosidase (AFU) USA: For Research Use Only EU: Features The Diazyme AFU Assay is a single reagent, one step method that has a linear range of U/L. The reagent is ready-to-use for both manual and automatic chemistry analyzers. The assay is specific for AFU and has no detectable reaction with other glycosidases. The assay is not affected by serum bilirubin up to 100 mg/dl, hemoglobin up to 200 mg/dl, triglycerides up to 750 mg/dl, or ascorbic acid up to 4.4 mg/dl. The assay has precisions of Intra %CV < 5.1% and Inter CV% <6.2%. The AFU Assay is based on the enzymatic cleavage of the synthetic substrate 2-chloro- 4-nitrophenyl-α-L-fucopyranoside to α-l-fucoside and 2-chloro-4-nitrophenol, which is quantified by measuring the absorbances at 405 nm in a kinetic fashion. It is a one step assay with a single assay reagent. One unit of AFU is defined as the amount of AFU that cleaves one μmole of 2-chloro-4-nitrophenyl-α-L-fucoside per min at 37 C. The α-l-fucosidase (AFU) assay kit is for determination of AFU activity in serum samples. Kit (200 Tests) DZ082B-K DZ082B-CAL DZ082B-CON R1: 2 x 25 ml 1 x 1 ml vial 1 x 1 ml vial Colorimetric/Kinetic, 19 (888)-DIAZYME (Toll Free US only)

20 LIVER MARKERS Total Bilirubin Assay 510(k) Cleared Features Diazyme s Total Bilirubin Assay is a dual stable liquid method that provides an enhanced level of accuracy, reliability and freedom from interference compared to conventional Diazo procedures. The test offers an extended testing range of 0.1 to 40 mg/dl, provides excellent precision with Intra-Assay Precision of CV% of <8%, Inter-Assay Precision CV% of <2%. The assay demonstrates no significant interference from ascorbate acid up to 50 mg/dl and hemoglobin up to at least 500 mg/dl. With a unique combination of low sample size requirements and interference free testing, Diazyme s Total Bilirubin Assay is an ideal choice. When a sample is mixed with the reagent containing the detergent and the vanadate, at around ph 3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the absorbance s before and after the vanadate oxidation. The Diazyme Total Bilirubin Assay is an in vitro colorimetric assay for the quantitative determination of total bilirubin in serum. Determination of serum bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice. Kit (900 Tests) DZ150A-K DZ150A-CAL DZ150A-CON R1: 4 x 70 ml R2: 4 x 18 ml 1 x 3 ml vial 2 x 5 ml vial Colorimetric, Endpoint, Direct Bilirubin Assay 510(k) Cleared Features Diazyme s Direct Bilirubin Assay is a dual stable liquid method that provides an enhanced level of accuracy, reliability and freedom from interference compared to conventional Diazo procedures. The test offers an extended testing range of 0.1 to 20 mg/dl, provides excellent precision with Intra-Assay Precision of CV% of <3%, Inter-Assay Precision CV% of <4%. The assay demonstrates no significant interference from ascorbate acid up to 50 mg/dl and hemoglobin up to at least 500 mg/dl. With a unique combination of low sample size requirements and interference free testing Diazyme Direct Bilirubin Assay is an ideal choice. When a sample is mixed with the reagent containing the vanadate, at around ph 3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation. The Diazyme Direct Bilirubin Assay is an in vitro colorimetric assay for the quantitative determination of direct bilirubin in serum. Determination of serum bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice. Kit (900 Tests) DZ151A-K DZ150A-CAL DZ150A-CON R1: 4 x 70 ml R2: 4 x 18 ml 1 x 3 ml vial 2 x 5 ml vial Colorimetric, Endpoint, (858)

21 ELECTROLYTES Enzymatic Potassium Assay 510(k) Cleared Features Diazyme s Potassium Assay has an outstanding linearity range from 2.0 mmol/l 8.0 mmol/l. Diazyme s Potassium Assay offers excellent precision CV% of <2%. A comparison study showed that the assay has good correlation with existing ISE method s with a correlation coefficient value of 0.98, slope of 1.07 and y intercept of The assay shows virtually no affect by the following interfering substances at indicated concentrations: Na+ 150mM, NH mm, Ca mm, Pi 2.0 mm, ascorbic acid 10.0 mm, Zn mm, Fe mm, Cu mm, triglycerides 1000 mg/dl, hemoglobin 500 mg/dl, conjugated bilirubin 20 mg/ dl and unconjugated bilirubin 15 mg/dl. Potassium is determined spectrophotometrically through a kinetic coupling assay system using potassium dependent pyruvate kinase. Pyruvate generated is converted to lactate accompanying conversion of NADH analog to NAD analog. The corresponding decrease of optical density at 380 nm is proportional to the potassium concentration in the serum. For in vitro quantitative determination of potassium in human serum. Measurements obtained by this assay are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Kit (720 Tests) DZ113C-K DZ113C-CAL DZ113C-CON R1: 4 x 40 ml R2: 4 x 10 ml Cal: 2 x 3 ml vial ( Included) 2 x 3 ml vial 2 x 3 ml vial Enzymatic/Kinetic, Enzymatic Sodium Assay 510(k) Cleared Features Diazyme s Sodium Assay has good correlation with the ISE method and has a linear method between sodium concentrations of 80 and 180 mmole/l (184 and 414 mg/dl). The assay has CV s% of <2% with a correlation coefficient of 0.98, slope of 1.05 and a y intercept of The following substances normally present in serum produced less than 10% deviation at the listed concentrations: NH 4 Cl at 1.5 mm, KPi at 2.0 mm, CaCl 2 at 7.5 mm, KCl at 10 mm, CuCl 2 at 0.5 mm, ZnCl 2 at 0.5 mm, FeCl 3 at 0.5 mm, Glucose at 5 mm, ascorbate 10 mm, bilirubin at 40 mg/dl, bilirubin conjugate 40 mg/dl, hemoglobin 500 mg/dl, and triglyceride 1000 mg/dl. Sodium is determined enzymatically via sodium-dependent β- galactosidase activity with ONPG as the substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration. Diazyme Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Kit (720 Tests) DZ114B-K DZ114B-CAL DZ114B-CON R1: 4 x 40 ml R2: 4 x 20 ml Cal: 2 x 3 ml vial ( Included) 2 x 3 ml vial 2 x 3 ml vial Enzymatic/Kinetic, 21 (888)-DIAZYME (Toll Free US only)

22 ELECTROLYTES Enzymatic Lithium Assay 510(k) Cleared Features Diazyme s Lithium Assay provides a convenient, stable, non-caustic low cost alternative to expensive ISE and highly caustic alkaline Lithium methods. Diazyme s Lithium Assay demonstrates an excellent correlation with ISE methods and offers excellent precision CV% of <5% and a measuring range from 0.19 mmol/l 3.0 mmol/l. The assay is not interfered by the following substances at indicated concentrations: Na+ 200 mm, NH mm, Ca mm, Mg mm, ascorbic acid 5.0 mm, 0.25 mm Zn 2+, 0.25 mm Fe 3+, 0.25 mm Cu 2+, 10 mm K+, Triglycerides 1000 mg/dl, conjugated bilirubin 20 mg/dl and unconjugated bilirubin 45 mg/ dl, Ascorbic Acid 5 mm and hemoglobin 500 mg/dl. Lithium is determined spectrophotometrically through a kinetic coupled enzyme assay system involving Diazyme s proprietary phosphatase 1 whose activity is sensitive to lithium (IC50=0.1mM). Through enzymatic coupling, the phosphatase substrate is converted to hypoxanthine by a series of enzymatic reactions to generate uric acid and hydrogen peroxide (H 2 O 2 ). H 2 O 2 generated reacts with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline (EHSPT) and 4-aminoantipyrine (4-AA) in the presence of peroxidase (POD) to form a quinone dye which has maximal absorbance at 556 nm. The rate of the quinine dye formation is inversely proportional to the concentration of lithium in serum samples. Diazyme Lithium Enzymatic Assay kit is for quantitative in vitro determination of lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity. Kit (200 Tests) Alternate DZ116B-K DZ116B-CAL DZ116B-CA5 DZ116B-CON R1: 2 x 20 ml R2: 2 x 10 ml Cal: 3 x 3 ml vial ( Included) 3 x 3 ml vial 5 x 3 ml vial 2 x 3 ml vial Enzymatic/Kinetic, Liquid stable Carbon Dioxide (CO 2 ) Assay 510(k) Cleared Features Diazyme s CO 2 Enzymatic Assay is a single vial liquid stable reagent system which has a neutral ph, minimizing the effect of CO 2 absorption from the air. In addition to a highly stable NADH analog as a co-factor the reagent maintains integrity by rebuilding key reagent components as required for optimal performance. The assay has a linearity of mmol/l, correlation coefficient value of 0.99, slope of , y intercept of and is highly precise with Intra and Inter Assay Precision %CV s of <3.5%. Packaged for optimal operator convenience, reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche TM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC. Diazyme Carbon Dioxide Enzymatic Assay is based on two coupled enzyme reactions including phosphoenolpyruvate carboxylase (PEPC) and malate dehydrogenase (MDH). PEPC catalyzes the first reaction which produces oxaloacetate. In the presence of MDH, the reduced cofactor is oxidized by oxaloacetate. This results in a decrease of absorbance at 405 or 415 nm that is directly proportional to CO 2 concentration in the sample. Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide, are intended for the quantitative determination of carbon dioxide (CO 2 ) in serum and plasma. For in vitro diagnostics use only. Kit (300 Tests) DZ122A-K DZ122A-CAL DZ122A-CON R1: 5 x 20 ml Cal: 1 x 2 ml vial ( Included) 1 x 2 ml vial 2 x 2 ml vial Colorimetric/Kinetic, Liquid stable (858)

23 INFLAMMATORY MARKERS hscrp Assay 510(k) Cleared Features The Diazyme High Sensitive C-Reactive Protein (hscrp) Assay has a linear range of mg/l that extends below the measurement range typical of most conventional CRP assay's. This lower range of measurement may include the evaluation of conditions thought to be associated with inflammation in otherwise healthy individuals. The assay is based on a latex-enhanced turbidimetric immunoassay method. When an antigen-antibody reaction occurs between CRP in a sample and anti-crp antibody which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration. The Diazyme High Sensitivity C-Reactive Protein (hscrp) Assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only. Kit (240 Tests) DZ135A-K DZ135A-CAL DZ135A-CON R1: 1 x 60 ml R2: 1 x 14 ml 4 x 1 ml vial 3 x 3 ml vial Latex-enhanced Immunoturbidimetric, Myeloperoxidase (MPO) Immunoassay USA: For Research Use Only EU: Features The linearity of the assay is from ng/ml ( pm) in heparin plasma with intra-assay % CV 5%. The following substances normally present in the plasma were tested at levels equal to the following concentrations. Ascorbic acid (10mM), bilirubin (free) (40 mg/dl), conjugated bilirubin (40 mg.dl), triglycerides (270 mg/dl), Hemoglobin (200 mg/dl), Rheumatoid Factor (75 IU/mL) produced less than 10% deviation when tested. Diazyme s MPO Immunoassay is based on a latex enhanced immunoturbidimetric assay. MPO proteins in the sample bind to the specific anti-mpo antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of MPO in the sample. The instrument calculates the MPO concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve. Diazyme MPO Immunoassay is for the quantitative determination of myeloperoxidase in plasma by latex enhanced immunoturbidimetric method. Kit (200 Tests) DZ178C-K DZ178C-CAL DZ178C-CON R1: 1 x 44 ml R2: 1 x 14 ml 5 x 1 ml vial 2 x 3 ml vial Latex Enhanced Immunoturbidimetric Assay, 23 (888)-DIAZYME (Toll Free US only)

24 COAGULATION D-Dimer Assay 510(k) Cleared Features Diazyme s D-Dimer Assay is a highly sensitive liquid stable latex enhanced immunoturbidimetric test kit, designed to work on most open clinical chemistry analyzers to provide rapid results with reduced reagent cost. The D-Dimer Assay has a linearity of µg/ml FEU with a correlation coefficient value of 0.939, slope of and y intercept of The following substances do not interfere with this assay at the levels tested less than 10% bias: Hemoglobin up to 500 mg/dl, Bilirubin 40 mg/dl, Bilirubin conjugated 40mg/dL, Triglycerides 1000 mg/dl, Ascorbic Acid 176 mg/dl, Rheumatoid Factor 100 IU/mL, Heparin 1.5 IU/mL and HAMA 490 ng/ml. Diazyme s D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-d-dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The Roche TM Modular P calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve. Diazyme s D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only. Kit (100 Tests) DZ179A-K DZ179A-CAL DZ179A-CON R1: 1 x 20 ml R2: 1 x 8 ml 5 x 1 ml vial 2 x 1 ml vial Latex Enhanced Immunoturbidimetric Assay, CANCER MARKERS α-fetoprotein (AFP) Assay USA: For Research Use Only EU: Features Diazyme s Alpha Fetoprotein (AFP) is a dual liquid stable reagent system which provides reliable results. The method requires only 7 μlof sample, completed in less than 10 minutes, and has excellent correlation with existing commercial products with R 2 of , a slope of and a y intercept of The assay has within-run precision values of less than 7.6%. Diazyme s α-fetoprotein Assay is based on a latex enhanced immunoturbidimetric assay. AFP in the sample binds to the specific anti-afp antibodies, which are coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of AFP in the sample. The instrument calculates the AFP concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve. The Diazyme α-fetoprotein Assay is for the determination of α-fetoprotein concentration in serum or plasma by latex enhanced immunoturbidimetric method. Kit (200 Tests) DZ869A-K DZ869A-CAL DZ869A-CON R1: 1 x 48 ml R2: 1 x 15 ml 5 x 2 ml vial 2 x 2 ml vial Latex Enhanced Immunoturbidimetric Assay, (858)

25 25-Hydroxy Vitamin D EIA Kit 510(k) Cleared Features This innovative new assay uses enzyme immunoassay technology (EIA) to quantify total 25-OH vitamin D (D2+D3) from serum or plasma samples in about two hours. The test can be run on both manual and automated microplate readers. Test accuracy is assured by a fully automated extraction step that removes proteins in the sample that may interfere with test performance. The method is highly precise with Intra-assay %CV of 15% for samples 15 ng/ml. The test correlates well to current methods. When tested with samples ranging from 11.9 ng/ml ng/ml the correlation coefficient was R 2 = with a slope of and a y intercept of 1.4 ng/ml. The assay is directly traceable to the industry standard NIST SRM 972 and has demonstrated excellent performance with the DEQAS proficiency program. The assay is based on the competition between a 25-OH vitamin D conjugate coated on a microplate and the 25-OH Vitamin D content of a sample. Vitamin D is extracted (EX Reagent) from your samples and then mixed, in the coated microplate well breakaway plates, with reagent R1 which contains an antibody for 25-OH Vitamin D. After a first incubation, the microplate is washed and reagent R2 (HRP-labeled secondary antibody) is added. Following a second incubation and a washing step, reagent R3 (TMB substrate) is added. After a final incubation step, the reaction is stopped by adding the STOP solution and the colorimetric signal of the microplate is measured at 450 nm (primary wavelength) to which the background signal can be subtracted by using secondary wavelengths (620 to 650 nm). The 25-OH Vitamin D concentration of a patient sample is inversely proportional to the measured absorbance at 450 nm. The whole assay procedure takes about two hours. VITAMIN MARKERS The Diazyme 25-OH Vitamin D EIA Kit is designed for the quantification of total 25-OH Vitamin D in human serum and plasma. The assay results are to be used in parallel with other clinical data to assess the Vitamin D status of a patient. For in vitro diagnostics use only. Kit (96 Tests) DZ688B-K DZ688B-CON R1: 1 x 23 ml R2: 1 x 23 ml R3: 1 x 23 ml Extraction: 1 x 30 ml Stop: 1 x 15 ml Cal: 6 x 1 ml vial ( Included) 2 x 1 ml vial Enzyme Immunoassay, 25 (888)-DIAZYME (Toll Free US only)

26 VITAMIN MARKERS 25-OH Vitamin D Assay for Clinical Chemistry Analyzers 510(k) Cleared Features Diazyme s Vitamin D Assay for Clinical Chemistry Analyzers is a three liquid stable reagent system which provides reliable results. The method requires only 20 μl of sample, completed in less than 19 minutes, and has excellent correlation with existing commercial products with R 2 of 0.963, a slope of and a y intercept of The assay has within-run precision values of 8.7% and a between-run precision value of 9.1%. The test is based on the principle of a-complementation of the enzyme β-galactosidase and the competition between an enzyme donor-25-oh Vitamin D conjugate, an anti- Vitamin D antibody and the 25-OH Vitamin D content of a serum sample. Samples with higher 25-OH Vitamin D concentrations produce higher β-galactosidase activities and vice versa. A nitrophenyl-ß- galactoside derivative (NPG) is used as the enzyme substrate. The reaction's product has maximum absorbance at 415 nm. The 25-OH Vitamin D concentration of a sample is proportional to the measured β-galactosidase activity. The Diazyme 25-OH Vitamin D Assay is designed for the quantification of total 25-OH Vitamin D in serum and plasma samples. Kit (80 Tests) DZ688C-K DZ688C-CON Diluent: 1 x 17 ml R1: 1 x 8.5 ml R2: 1 x 17 ml R3: 1 x 8.5 ml Cal: 5 x 1 ml ( Included) 2 x 1 ml vial Enzyme Immunoassay, (858)

27 NOTES 27 (888)-DIAZYME (Toll Free US only)

28 Instrument Specific - Beckman CARDIOVASCULAR MARKERS Homocysteine Enzymatic Assay (Three Vial Format) 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ568A-K04 Beckman Synchron Homocysteine Enzymatic Assay Kit R1: 2 x 22 ml R2: 2 x 3.7 ml R3: 2 x 2.5 ml 135 DZ568A-K05 Beckman Synchron Homocysteine Enzymatic Assay Kit R1: 2 x 45 ml R2: 2 x 9 ml R3: 2 x 5.7 ml 340 Homocysteine Enzymatic Assay (Dual Vial Format) 510(k) Cleared DZ568B-BY1 DZ568B-BY2 Beckman AU Beckman AU Lipoprotein (a) [Lp(a)] Assay 510(k) Cleared DZ131A-KB1 DZ131A-KY1 Beckman Synchron Beckman AU Homocysteine Enzymatic Assay Kit Homocysteine Enzymatic Assay Kit Lp(a) Lipoprotein Test Kit Lp(a) Lipoprotein Test Kit R1: 1 x 52 ml R2: 1 x 15 ml R1: 2 x 52 ml R2: 2 x 15 ml R1: 1 x 60 ml R2: 1 x 20 ml R1: 1 x 60 ml R2: 1 x 20 ml HDL Cholesterol Assay 510(k) Cleared DZ129A-KB1 DZ129A-KY1 Beckman Synchron Beckman AU LDL Cholesterol Assay 510(k) Cleared HDL-Cholesterol Test Kit HDL-Cholesterol Test Kit R1: 4 x 60 ml R2: 4 x 20 ml R1: 5 x 56 ml R2: 2 x 50 ml DZ128A-KB1 Beckman Synchron LDL-Cholesterol Test Kit R1: 4 x 60 ml R2: 4 x 20 ml 960 DZ128A-KY1 Beckman AU LDL-Cholesterol Test Kit R1: 5 x 56 ml R2: 2 x 50 ml 1120 (858)

29 Instrument Specific - Beckman DIABETIC MARKERS Direct Enzymatic HbA1c Assay IFCC Certified 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ168A-KB1 DZ168A-KY2 Beckman Synchron Beckman AU Direct Enzymatic HbA1c Test Kit Direct Enzymatic HbA1c Test Kit Lysis Buffer: 1 x 20 ml R1a: 1 x 15 ml R1b: 1 x 5 ml R2: 1 x 5.5 ml Lysis Buffer: 2 x 60 ml R1a: 2 x 33 ml R1b: 2 x 14.1 ml R2: 2 x 19 ml Insulin Assay 510(k) Exempt Catalog No. Type Description Format Test/Kit DZ865A-KY1 Beckman AU Insulin Test Kit R1: 1 x 13.5 ml R2: 1 x 5 ml 100 RENAL AND PANCREATIC MARKERS Enzymatic Creatinine Assay 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ072B-KY1 Beckman AU Enzymatic Creatinine Test Kit R1: 2 x 60 ml R2: 2 x 20 ml 400 Cystatin C Assay 510(k) Cleared DZ133C-KB1 Beckman Synchron Enzymatic Cystatin C Test Kit R1: 1 x 60 ml R2: 1 x 18 ml 215 DZ133C-KY1 Beckman AU Enzymatic Cystatin C Test Kit R1: 1 x 60 ml R2: 1 x 12 ml 215 DZ133C-KY2 Beckman AU Enzymatic Cystatin C Test Kit R1: 2 x 60 ml R2: 2 x 12 ml 430 Lipase Assay 510(k) Exempt DZ132A-KY1 Beckman AU Lipase Test Kit R1: 2 x 50 ml R2: 2 x 11 ml (888)-DIAZYME (Toll Free US only)

30 Instrument Specific - Beckman LIVER MARKERS Total Bile Acids (Enzyme Cycling) Assay 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ042A-KB1 Beckman Synchron Total Bile Acids (Enzyme Cycling) Test Kit R1: 2 x 60 ml R2: 2 x 20 ml 400 DZ042A-KY1 Beckman AU Total Bile Acids (Enzyme Cycling) Test Kit R1: 2 x 60 ml R2: 2 x 20 ml 400 ELECTROLYTES Enzymatic Lithium Assay 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ116B-KB1 Beckman Synchron Enzymatic Lithium Test Kit R1: 1 x 20 ml R2: 1 x 10 ml Cal: 5 x 3 ml vial ( Included) 90 DZ116B-KB2 Beckman Synchron Enzymatic Lithium Test Kit R1: 2 x 20 ml R2: 2 x 10 ml Cal: 5 x 3 ml vial ( Included) 180 Carbon Dioxide (CO 2 ) Assay 510(k) Cleared DZ122A-KB1 DZ122A-KY2 Beckman Synchron Beckman AU Carbon Dioxide (CO 2 ) Test Kit 405 nm Carbon Dioxide (CO 2 ) Test Kit 405 nm R1: 4 x 100 ml 1200 R1: 10 x 56 ml 1680 (858)

31 Instrument Specific - Dimension (AR, Xpand, RxL, EXL) CARDIOVASCULAR MARKERS Homocysteine Enzymatic Assay (Three Vial Format) 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ568A-KD2 Dimension Specific Homocysteine Enzymatic Assay Kit R1: 2 x 16 ml R2: 2 x 4 ml R3: 2 x 3.5 ml 120 HDL Cholesterol Assay 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ129A-KD1 Dimension Specific HDL-Cholesterol Test Kit R1: 2 x 16 ml R2: 2 x 6 ml 96 DZ129A-KD2 Dimension Specific HDL-Cholesterol Test Kit R1: 4 x 16 ml R2: 4 x 6 ml 192 LDL Cholesterol Assay 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ128A-KD1 Dimension Specific LDL-Cholesterol Test Kit R1: 2 x 16 ml R2: 2 x 6 ml 96 DZ128A-KD2 Dimension Specific LDL-Cholesterol Test Kit R1: 4 x 16 ml R2: 4 x 6 ml 192 DIABETIC MARKERS Direct Enzymatic HbA1c Assay IFCC Certified 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ168A-KD1 Dimension Specific Direct Enzymatic HbA1c Test Kit Lysis Buffer: 15 ml R1a: 10.5 ml R1b: 4 ml R2: 7 ml 42 RENAL AND PANCREATIC MARKERS Cystatin C Assay 510(k) Cleared Catalog No. Type Description Format Test/Kit DZ133C-KD1 Dimension Specific Enzymatic Cystatin C Test Kit R1: 1 x 16 ml R2: 1 x 3.5 ml 60 *Please Note: Universal packaging is for Hitachi 917. All of our products can be transferred to user packaging and utilized on most major liquid chemistry analyzers. 31 (888)-DIAZYME (Toll Free US only)

32 A RAPID, RELIABLE TESTING PLATFORM HbA1c WITH A UNIQUE ASSAY HbA1c DISPLAY [510(k) Cleared] [510(k) Cleared] Homocysteine [510(k) Cleared] Cystatin C DIABETES MARKER [510(k) HbA1c Cleared] [510(k) Cleared] hscrp RENAL MARKER [510(k) Cleared] Cystatin C [510(k) Cleared] Procalcitonin (PCT)* Cystatin C [510(k) Cleared] hscrp INFLAMMATORY MARKER [510(k) Cleared] hscrp [510(k) Cleared] Glycated Serum Protein (GSP) CARDIAC MARKER [510(k) Homocysteine Cleared] [510(k) Cleared] Procalcitonin (PCT)* COMING SOON! Glycated Serum Protein (GSP)* Procalcitonin A RAPID, RELIABLE TESTING PLATFORM (PCT)* WITH A UNIQUE ASSAY DISPLAY *USA: For Research Use Only *USA: For Research Use Only DIAZYME (858) INNOVATIONS IN CLINICAL 32 DIAGNOSTICS

33 Smart 700/340 CARDIOVASCULAR MARKERS Homocysteine POC Test Kit Catalog No. Type Description Format Test/Kit DZ568B-SMA Reagent Kit Homocysteine POC Test Kit DZ568A-CON Enzymatic Homocysteine Four (4) Level Set (liquid) SEPSIS MARKERS Procalcitonin (PCT) POC Test Kit 20 x (R1: 0.56 ml, R2: 0.14 ml) 1 x RFID Card Con: 4 x 3 ml vial 20 Catalog No. Type Description Format Test/Kit DZ558A-SMA Universal Procalcitonin (PCT) POC Test Kit DZ558B-CON Procalcitonin Two (2) Level Set (lyophilized) 40 x (R1: 0.40 ml; R2: 0.13 ml) 1 RFID Card Con: 2 x 3 ml vial 40 DIABETIC MARKERS Direct Enzymatic HbA1c Test Kit Catalog No. Type Description Format Test/Kit DZ168B-POC Reagent Kit Direct Enzymatic HbA1c for SMART Analyzer DZ168B-CON Direct Enzymatic HbA1c for SMART Analyzer Two (2) Level Set (lyophilized) Glycated Serum Protein (GSP) POC Test Kit 20 x (Lysis Buffer: 0.25 ml, R1a: 0.7 ml, R2: 0.24 ml) R1b: 1 x 5 ml 1 x RFID Card Con: 2 x 0.5 ml vial 20 Catalog No. Type Description Format Test/Kit DZ112B-SMA Universal Glycated Serum Protein (GSP) POC Test Kit DZ112B-CON Glycated Serum Protein (Glycated Albumin) Two (2) Level Set (lyophilized) 40 x (R1: 0.40 ml; R2: 0.10 ml) 1 RFID Card Con: 2 x 1 ml vial (888)-DIAZYME (Toll Free US only)

34 Smart 700/340 (continued) RENAL AND PANCREATIC MARKERS Cystatin C POC Test Kit Catalog No. Type Description Format Test/Kit DZ133D-SMA Reagent Kit Cystatin C POC Test Kit DZ133D-CON Cystatin C Two (2) Level Set (liquid) 20 x (R1: 0.8 ml, R2: 0.3 ml) 1 x RFID Card Con: 2 x 1 ml vial 20 INFLAMMATORY MARKERS hscrp POC Test Kit Catalog No. Type Description Format Test/Kit DZ135B-SMA Reagent Kit hscrp POC Test Kit DZ135B-CON hscrp Two (2) Level Set (liquid) 40 x (R1: 1 ml R2: 0.25 ml) 1 x RFID Card Con: 2 x 1 ml vial 40 (858) (888)-DIAZYME (Toll Free US only)

35 Ordering Information Phone, Fax, or Orders You can place an order with us by phone, fax, or . To expedite your order, please provide the following information: 1) Customer name, phone, FAX and 2) Purchase order number or credit card information (Visa, Master Card, American Express, Discover, JCB and Diners Club accepted) 3) Diazyme product catalog number and product name 4) Quantity of the product to be purchased 5) Shipping and billing addresses Our international customers can make purchases by wire transfer or by letter of credit. To send a wire transfer, please contact Diazyme s Customer Service Department for payment information. When placing an order with a letter of credit (LC), please send the original LC by express mail to Diazyme Laboratories at the address listed below. Diazyme Laboratories Gregg Court Poway, California Fax: Phone: DIAZYME (Toll Free US Only) sales@diazyme.com Web Site: Diazyme Europe GmbH Zum Windkanal Dresden, Deutschland Fax: +49 (0) Phone: +49 (0) sales@diazyme.de Web Site: Webstore Orders Visit to place an order for finished kitted products. We accept (Visa, Master Card, American Express, Discover, JCB and Diners Club). For web support contact webstore@diazyme.com. Bulk Orders/Special Orders Diazyme Customer Service can generate customized quotations for bulk or special orders. Please send a quotation request including the following information to sales@diazyme.com: 1) Customer name, phone, FAX, and mailing address 2) Diazyme product catalog number and product name 3) Quantity and unit of the product to be purchased per order or per year Shipping, Sales Terms and Prices We strive to ship our products within 24 to 48 hours of receiving the order. prices do not include shipping fees. Please contact Customer Service for detailed sales terms, current pricing, and shipping options. All prices are subject to change without notice. Returns Diazyme products are manufactured under stringent quality assurance guidelines. Due to the nature of our products, we are not able to routinely accept returns. Please contact Customer Service with questions. Customer Service Our web site ( contains up-to-date information on our products including technical information such as assay method, assay accuracy, linearity range and reagent stability. Material Safety Data Sheets (MSDS) are available upon request. If you have additional questions, please contact us at the numbers listed above. 35 (888)-DIAZYME (Toll Free US only)

36 Diazyme Laboratories A Life Science Division of General Atomics Diazyme Europe GmbH Zum Windkanal Dresden, Deutschland Tel: +49 (0) Fax: +49 (0) sales@diazyme.com Diazyme Laboratories Gregg Court Poway, CA Tel: Fax: sales@diazyme.com Shanghai Diazyme Co., Ltd. Room 201, 1011 Halei Road Zhangjiang Hi-tech Park Shanghai, People s Republic of China Tel: Fax: service@lanyuanbio.com D076 (6/2014) MK051 Rev. M