PRODUCTS FOR EXPORT 2018

Transcription

1 PRODUCTS FOR EXPORT 2018 MEDICON HELLAS SA 5-7 Melitona st., Gerakas, Attiki, Greece - Tel.: FAX: diag@mediconsa.com, General Electronic Commercial Registry (G.E.MI.) No , Ex Reg. No: 16439/06/Β/88/24 - Company listed in the Athens Stock Exchange

2 Company profile Medicon is one of the largest companies in the field of laboratory diagnostics in Greece, and the only Greek in vitro diagnostics manufacturer with our own: Fully equipped R&D facility. Production plant for Clinical Chemistry, Hematology and Immunochemistry reagents. Refurbishment plant. Production of medical software and process optimization solutions for laboratories. Chain of diagnostic laboratories. We sell our branded products to Greek healthcare providers and several export customers and we also export products in bulk to world class IVD companies in a number of countries (Germany, Austria, UK, Italy, Finland, Spain, China, Slovenia, India, Latin America, etc). Over the years we have developed our own technology and flexibility that allow adapting our products to several types of automated laboratory analyzers and we offer our customers first class services and support. We have extensive expertise in reagents for Immunoturbidimetric assays (ITA). The performance characteristics of our ITA methods are among the best in the industry and our ITA reagents can be applied on several types of chemistry analyzers, offering fast and economic testing of a large variety of specific proteins. Our applications lab is equipped with modern types of analyzers from world-class manufacturers and undertakes application of our products on these systems. We strongly believe in ensuring peace-of-mind to users of our products, so we design our systemspecific reagents to perfectly match the individual analyzer type characteristics and workflow, and provide enhanced performance and user friendliness by prolonged on-board and calibration stability and by carefully selected pack sizes that eliminate waste. By developing refurbishment technology, we have on one hand ensured availability of instruments at very low cost. On the other, we export these systems mainly to the US, where they are accepted as high-value items, due to the excellent work we do to ensure a new, high performance life for these instruments. We apply a comprehensive Quality Assurance program that ensures high quality, and we have ISO9001 and ISO accreditation. All our products are CE marked according to the IVDD 98/79/EC, and several products are in the course of FDA submission. Our ISO 14001:2005 is testament to our consideration and care for minimizing our environmental impact. Ver. 2 Page 2 of 14

3 Products list We manufacture reagents for a large variety of tests listed below, in instrument-specific formats with system barcodes, specially designed for direct placement on analyzers. Our reagent lines are: 1. Reagents for direct placement on Beckman Coulter (ex-olympus) AU-series chemistry analyzers. 2. Reagents for direct placement on Siemens ADVIA 1800/2400 series chemistry analyzers. 3. Reagents for direct placement on Mindray BS200/220 E series chemistry analyzers (under development). 4. Reagents for manual or general purpose use. 5. Bulk reagents for OEM packaging. 6. Calibrators and controls. List of available tests A1 Acid Glycoprotein B2-Microglobulin Gamma GT Microalbumin A1 Antitrypsin Bilirubin, direct Glucose (GOD-POD) Myoglobin A1-Microglobulin Bilirubin, total Glucose (Hex) 5 Nucleotidase A2-Macroglobulin C3 Haptoglobin Phosphorus, inorganic ACE C4 HbA1c Phospholipids Acid phosphatase Calcium HDL Cholesterol Plasminogen ADA Cholesterol IgA Prealbumin Albumin Cholinesterase IgE Retinol binding protein Aldolase CK MB IgG Rheumatoid factor ALP CK NAC IgM stfr ALT (GPT) Creatinine Iron Protein, total Ammonia Creatinine, enzymatic Lactate Total Antioxidant Capacity Amylase, a- CRP LDH Transferrin Amylase, p- CRP (wr) LDL Cholesterol Triglycerides Amyloid a, serum Cystatin c κ light chains U-CSF Protein Antithrombin III D-Dimer λ light chains UIBC Apo A1 Ethanol Lipase Urea Apo B Ferritin Lipoprotein (a) Uric acid ASO Fibrinogen Lysozyme AST (GOT) G-6PDH Magnesium Note: The above tests have been fully developed and tested with several analytical platforms, however for each instrument-specific series we are manufacturing and packing ONLY certain tests as follows, for which commercial interest has been expressed. In case you cannot find a specific test of your interest in the lists below, please contact Medicon. Package inserts and Application sheets are available for download at the following link: Ver. 2 Page 3 of 14

4 AU-series reagents DESCRIPTION CODE R1 R2 # TESTS 5-NUCLEOTIDASE LYO A1 ACID GLYCOPROTEIN ,0 4 4,0 200 A1 MICROGLOBULIN ,3 4 4,3 68 A1-ANTITRYPSIN ,0 4 6,0 200 A2 MACROGLOBULIN ,0 2 8,0 200 AC. PHOSPHATASE ,0 1 5,0 240 ACE LYO ADA ,0 4 4,5 200 ALBUMIN BCG , ALBUMIN BCG ,0 620 ALDOLASE LYO ALP AMP ,0 4 45, ALP IFCC ,0 4 9,0 400 ALT ,0 4 12, ALT ,0 4 5,0 800 AMMONIA (ENZ.) ,0 2 3,0 120 AMYLASE IFCC ,0 4 8,0 800 AMYLASE IFCC ,0 4 2,0 200 APO A ,5 4 6,5 400 APO A ,3 4 3,3 200 APO B ,5 4 3,5 400 APO B ,3 4 1,8 200 ASO ,0 4 5,0 400 AST IFCC ,0 4 12, AST IFCC ,0 4 5,0 800 B2 MICROGLOBULIN ,0 2 3,0 100 BILIRUBIN DIRECT DPD ,5 4 52, BILIRUBIN DIRECT DPD ,0 4 30,0 800 BILIRUBIN TOTAL DPD ,5 4 52, BILIRUBIN TOTAL DPD ,0 4 30,0 800 C ,0 4 10,0 400 C ,0 4 2,5 100 C ,0 4 8,0 400 C ,0 4 2,0 100 CALCIUM , CALCIUM ,0 400 CERULOPLASMIN ,0 2 4,5 120 CHOLESTEROL , Ver. 2 Page 4 of 14

5 DESCRIPTION CODE R1 R2 # TESTS CHOLINESTERASE ,0 4 6,0 800 CHOLINESTERASE ,5 4 1,5 200 CK-MB LIQUID ,0 2 6,0 400 CK-NAC ,0 4 6,0 800 CK-NAC ,0 4 1,5 200 CREATININE ,0 4 25, CREATININE, ENZYMATIC ,0 4 15, CRP ,0 4 8,0 800 CRP ,0 4 2,0 200 CRP, LATEX ,0 4 9,0 400 CYSTATIN C ,0 2 3,0 200 D-DIMER ,0 4 2,5 200 ETHANOL LYO FERRITIN ,0 4 16,0 800 FERRITIN ,0 2 8,0 200 FIBRINOGEN ,5 4 2,5 200 G6PDH ,0 2 1,5 120 G-GT ,0 4 40, G-GT ,0 4 8,0 400 GLUCOSE GOD POD , GLUCOSE HEX ,0 4 15, HAPTOGLOBIN ,0 4 6,0 200 HbA1c ,6 4 7,6 400 HbA1c DENATURANT ,0 200 HDL CHOLESTEROL ,0 4 9,0 600 IgA ,0 4 10,0 400 IgA ,5 4 2,5 100 IgE ,3 4 2,0 200 IgG ,0 4 14,0 400 IgG ,5 4 3,5 100 IgM ,0 4 10,0 400 IgM ,5 4 2,5 100 IRON ,0 4 27, IRON ,0 4 18,0 800 KAPPA LIGHT CHAINS ,5 4 1,3 200 LACTATE ,0 4 6,0 200 LAMBDA LIGHT CHAINS ,5 4 1,3 200 LDH L-P ,0 4 40, LDH L-P ,0 4 8,0 400 LDH P-L ,0 4 12, Ver. 2 Page 5 of 14

6 DESCRIPTION CODE R1 R2 # TESTS LDH P-L ,0 4 2,5 400 LDL CHOLESTEROL "DIRECT" ,0 4 9,0 600 Lp(a) ,0 4 9,0 400 Lp(a) ,0 4 4,5 200 MAGNESIUM ,0 800 MAGNESIUM ,0 300 MICROALBUMIN ,0 4 6,0 400 MICROALBUMIN ,0 4 3,0 200 PHOSPHOLIPIDS ,0 4 5,0 200 PHOSPHOROUS , PHOSPHOROUS ,0 400 PLASMINOGEN ,0 4 2,8 200 PREALBUMIN ,5 4 8,0 400 RF ,0 4 3,0 400 stfr ,0 4 6,0 400 stfr ,0 4 3,0 200 TOTAL ANTIOX. CAPACITY ,0 2 7,5 120 TOTAL PROTEIN ,0 4 50, TOTAL PROTEIN ,0 4 20,0 800 TRANSFERRIN ,0 4 10,0 400 TRANSFERRIN ,0 4 5,0 200 TRIGLYCERIDES ,0 4 12, UIBC ,5 4 5,0 400 UREA ,0 4 50, URIC ACID ,0 4 50, URIC ACID ,0 4 20,0 800 URINARY PROTEIN ,0 400 Please note that: 1. The reagent quantities shown above are actual useful quantities. Reagent containers are filled with the instrument dead volume taken in account. 2. Certain reagent kits contain freeze dried or extra components like R1b, R2b, R3, and/or calibrators. Please refer to individual package inserts for details. 3. The number of tests per kit shown above refers to AU400/640 applications. Applications for the AU2700, which also apply to AU480 and AU640 analyzers, are also available. 4. The above reagents are (with very few exceptions) liquid, ready to use. Please refer to individual package inserts for details. Ver. 2 Page 6 of 14

7 Siemens ADVIA 1800/2400 series reagents DESCRIPTION CODE R1 R2 TESTS 5 NUCLEOTIDASE LYO 4 9,0 200 A1 ACID GLYCOPROTEIN ,0 4 4,0 320 A1 MICROGLOBULIN ,0 4 5,0 100 A2 MACROGLOBULIN ,0 2 4,0 200 ACE LYO 2 10,0 200 ADA ,0 4 6,0 360 ALBUMIN , ALBUMIN ,0 800 ALKALINE PHOSPHATASE ,0 4 68, ALKALINE PHOSPHATASE ,0 4 15,0 600 APO A ,0 4 10,0 800 APO A ,0 4 4,5 320 APO B ,0 4 10,0 800 APO B ,0 4 4,5 320 ΑSΟ ,0 4 4,0 400 B 2 MICROGLOBULIN ,0 4 7,0 600 C ,0 4 6,0 720 C ,0 4 3,0 320 C ,0 4 6,0 720 C ,0 4 3,0 320 CALCIUM , CALCIUM , CERULOPLASMIN ,0 2 5,5 300 CHOLESTEROL , CHOLINESTERASE ,0 4 4,5 800 CHOLINESTERASE ,0 4 3,0 320 CK MB LYO 6 10,0 480 CK MB LIQUID ,0 2 9,0 600 CREATININE ,0 4 19, CREATININE, ENZYMATIC ,0 4 27, CRP LATEX ,0 4 6,0 400 CRP ,0 4 10, CRP ,0 4 4,0 400 CYSTATIN C ,0 4 3,0 400 D DIMER ,0 4 4,0 320 FERRITIN ,0 4 16, FERRITIN ,0 4 6,0 400 G 6PDH ,0 2 4,0 200 G GT ,0 4 68, G GT ,0 4 19,0 800 GLUCOSE HEXOKINASE ,0 4 18, HDL CHOLESTEROL ,0 6 7, IGA ,0 4 5,0 600 IGA ,0 4 3,0 320 Ver. 2 Page 7 of 14

8 DESCRIPTION CODE R1 R2 TESTS IGE ,0 4 3,5 400 IGG ,0 4 5,0 600 IGG ,0 4 3,0 320 IGM ,0 4 5,0 600 IGM ,0 4 3,0 320 INORGANIC PHOSPHORUS ,0 4 34, INORGANIC PHOSPHORUS ,0 4 15, IRON ,0 4 15, IRON ,0 4 9,0 800 KAPPA LIGHT CHAINS ,5 4 2,0 240 LACTATE ,0 4 6,0 200 LAMBDA LIGHT CHAINS ,5 4 2,0 240 LDH (L P) ,0 4 68, LDH (L P) ,0 4 19,0 800 LDL CHOLESTEROL ,0 4 6,0 600 LP(A) ,0 4 9,5 600 LP(A) ,5 4 5,0 280 LYSOZYME LYO 4 9,0 240 MAGNESIUM ,0 800 MAGNESIUM ,0 400 MICROALBUMIN ,0 4 5,0 400 MICROALBUMIN ,0 4 9,0 800 PHOSPHOLIPIDS ,5 4 7,0 400 PREALBUMIN ,0 2 3,0 200 RF ,0 4 4,0 400 SGOT/AST ,0 4 20, SGOT/AST ,0 4 9, SGPT/ALT ,0 4 20, SGPT/ALT ,0 4 9, STFR ,0 2 9,0 400 T. PROTEIN ,0 4 52, T. PROTEIN ,0 4 16,0 800 TOTAL ANTIOX. CAPACITY ,0 2 4,0 100 TRANSFERRIN ,0 4 12,0 900 TRANSFERRIN ,0 4 6,0 440 TRIGLYCERIDES ,0 4 18, UIBC ,5 4 7,0 800 URINARY CSF PROTEIN ,0 776 Please note that: 1. The reagent quantities shown above are actual useful quantities. Reagent containers are filled with the instrument dead volume taken in account. 2. Certain reagent kits contain freeze dried or extra components like R1b, R2b, R3, and/or calibrators. Please refer to individual package inserts for details. 3. The above reagents are (with very few exceptions) liquid, ready to use. Please refer to individual package inserts for details. Ver. 2 Page 8 of 14

9 Mindray BS-200/220E series DESCRIPTION CODE R1 R2 TESTS ALBUMIN ,0 200 ALKALINE PHOSPHATASE ,0 4 15,0 400 ALT ,0 4 4,0 400 AMYLASE ,0 200 ASO ,5 4 2,5 200 AST ,0 4 4,0 400 BILIRUBIN, DIRECT ,0 4 0,5 200 BILIRUBIN, TOTAL ,0 4 0,5 200 CALCIUM ,0 200 CHOLESTEROL ,0 600 CK-MB ,0 4 2,0 200 CPK ,0 4 2,0 200 CREATININE ,0 4 15,0 400 CRP ,0 4 2,0 200 FERRITIN ,5 4 7,5 200 GGT ,0 4 5,0 400 GLUCOSE ,0 600 HDL-CHOLESTEROL ,0 4 6,7 400 IRON ,5 4 7,5 200 LDH L-P ,5 4 7,5 200 LDH P-L ,0 4 2,0 200 LDL-CHOLESTEROL ,0 4 3,4 200 MAGNESIUM ,0 200 PHOSPHORUS ,0 400 PROTEIN, TOTAL ,5 4 7,5 200 TRIGLYCERIDES ,0 600 UREA ,0 4 15,0 400 URIC ACID ,5 4 22,5 600 Please note that: 1. The reagent quantities shown above are actual useful quantities. Reagent containers are filled with the instrument dead volume taken in account. 2. The above reagents are liquid, ready to use. Please refer to individual package inserts for details. Ver. 2 Page 9 of 14

10 General purpose reagents CODE DESCRIPTION METHOD VOLUME () 141G-0163 A-AMYLASE BLOCKED EPS G7 3x40 + 3x10 141G-0164 A-AMYLASE G3CNP 3x50 141G-0194 ALBUMIN BCG 3x50 141G-0132 ALP PNPP-AMP 3x25 + 3x25 141G-0083 ALT/SGPT MODIFIED IFCC W/O P5P 3x40 + 3x10 141G-0550 APO A1 ITA 3x16 + 3x4 141G-0560 APO B ITA 3x16 + 3x4 141G-0073 AST/SGOT MODIFIED IFCC W/O P5P 3x40 + 3x10 141G-1060 ASΟ LATEX ITA 3x15 + 3x3 141G-0152 BILIRUBIN, DIRECT DPD 3x25 + 3x25 141G-0153 BILIRUBIN, DIRECT MALLOY-EVELYN 2x50 + 1x5 141G-0142 BILIRUBIN, TOTAL DPD 3x25 + 3x25 141G-0143 BILIRUBIN, TOTAL MALLOY-EVELYN 2x50 + 1x5 141G-0760 C3 ITA 3x16 + 3x4 141G-0750 C4 ITA 3x16 + 3x4 141G-0202 CALCIUM o-cpc 3x25 + 3x25 141G-0204 CALCIUM ARSENAZO III 3x50 141G-0041 CHOLESTEROL CHOD-POD 1x G-0044 CHOLESTEROL CHOD-POD 6x50 141G-0297 CK-MB IMMUNOINHIBITION 3x40 + 3x10 141G-0093 CK-NAC IFCC 3x40 + 3x10 141G-0033 CREATININE ENZYMATIC 3x30 + 3x10 141G-0032 CREATININE JAFFE 3x25 + 3x25 141G-0520 CRP ITA 3x16 + 3x4 141G-0525 CRP Latex LATEX ITA 3x16 + 3x4 141G-0590 Cystatin C LATEX ITA 3x16 + 3x4 141G-1182 D-Dimer LATEX ITA 3x16 + 3x4 141G-0271 FERRITIN LATEX ITA 3x15 + 3x5 141G-0102 G-GT IFCC 3x40 + 3x10 141G-0013 GLUCOSE HEXOKINASE UV 3x40 + 3x10 141G-0014 GLUCOSE GOD-POD 6x50 141G-0243 HDL-CHOLESTEROL IMMUNOINHIBITION 3x30 + 3x10 141G-0780 IgA ITA 3x16 + 3x4 141G-0790 IgG ITA 3x16 + 3x4 141G-0770 IgM ITA 3x16 + 3x4 141G-0122 IRON FERROZINE 3x25 + 3x25 141G-1092 LACTATE ENZYMATIC COLORIMETRIC 1x25 + 1x25 141G-0112 LDH L P IFCC 3x25 + 3x25 141G-0113 LDH P L SFBC 3x40 + 3x10 141G-0223 LDL -CHOLESTEROL IMMUNOINHIBITION 3x30 + 3x10 141G-0254 MAGNESIUM XYLIDYL BLUE 3x50 141G-0214 PHOSPHATE MOLYBDATE UV 6x50 Ver. 2 Page 10 of 14

11 CODE DESCRIPTION METHOD VOLUME (ML) 141G-1030 RF LATEX ITA 3x15 + 3x5 141G-0184 TOTAL PROTEIN BIURET 6x50 141G-0740 TRANSFERRIN LATEX ITA 3x12 + 3x6 141G-0062 TRIGLYCERIDES GPO-PAP 3x40 + 3x10 141G-0064 TRIGLYCERIDES GPO-PAP 6x50 141G-0281 UIBC NITROSO - PSAP 2x50 + 1x7, G-0022 UREA UREASE UV 3x25 + 3x25 141G-0052 URIC ACID URICASE PAP 3x25 + 3x25 141G-0189 URINARY - CSF PROTEIN PYROGALLOL RED 3x50 Notes: 1. Additional test items in GP packaging may be made available upon request. 2. Sales of these items can only be reserved for customers supplying binding forecasts. 3. Package inserts contain application data for manual use. These products may be used with automated open-system chemistry analyzers, after individual application protocols are developed and programmed in the analyzer menu. Medicon does not make performance claims for automated use. 4. These kits include standard solutions for calibration, where required. For automated use with open-system chemistry analyzers, our calibrators listed below may also be used for convenience. Ver. 2 Page 11 of 14

12 Calibrators and control materials DESCRIPTION CODE FORM VOLUME () 5-NUCLEOTIDASE CONTROL LYO 2x1 A1 MICROGLOBULIN CAL LRTU 6x1x1 A1 MICROGLOBULIN CON LRTU 3x1 ACE CALIBRATOR LYO 6x1 ACE CONTROL LYO 2x3x1 ADA CALIBRATOR LYO 4x1 ADA CONTROL LYO 2x3x1 ALDOLASE CALIBRATOR LYO 3x1 ALDOLASE CONTROLS LYO 2x3x1 AMMONIA CALIBRATOR LRTU 2x5 AMMONIA CONTROL LRTU 2x2x5 APO-A1/APO-B CALIBRATOR LRTU 3x1x1 APO-A1/APO-B CONTROL LEVEL LRTU 3x3 APO-A1/APO-B CONTROL LEVEL LRTU 3x3 ASO CALIBRATOR LRTU 5x1x1 B-2-MICROGLOBULIN CAL 4X LRTU 4x1x1 CK-MB CALIBRATOR LYO 3x1 CK-MB CONTROL LYO 2x3x2 CLINICAL CHEMISTRY CONTROL LEVEL LYO 12x5 CLINICAL CHEMISTRY CONTROL LEVEL LYO 12x5 CRP CALIBRATOR LRTU 5x1x1 CRP LATEX CALIBRATOR LRTU 5x1x1 CYSTATIN-C CALIBRATOR LRTU 6x1x1 CYSTATIN-C CONTROL LRTU 2x3x2 D-DIMER CALIBRATOR LYO 5x1x1 D-DIMER CONTROL LYO 2x2x1 ETHANOL CALIBRATOR LRTU 2x5 ETHANOL CONTROL LRTU 2x2x5 FERRITIN CALIBRATOR LRTU 5x1x1 FERRITIN CONTROL LRTU 2x2x1 FIBR/PLG CALIBRATOR LYO 4x1 FIBR/PLG CONTROL LYO 2x3x1 G6PDH CONTROLS LYO 3x2x0,5 HbA1c CALIBRATOR LRTU 1x8 + 5x1x2 HbA1c CONTROL LYO 2x2x0,25 IGE CALIBRATOR LRTU 4x1x1 Ver. 2 Page 12 of 14

13 DESCRIPTION CODE FORM VOLUME () IMMUNOLOGY CONTROL LRTU 4x3 IMMUNOLOGY CONTROL LRTU 4x3 IMMUNOLOGY CONTROL LRTU 4x3 LACTATE CALIBRATOR LRTU 3x2 LP(a) CALIBRATOR LRTU 6x1 LP(a) CONTROL HIGH LRTU 6x1 LP(a) CONTROL LOW LRTU 6x1 MALB/UPROT CONTROL LRTU 2x3x3 MEDI-CAL CHEMISTRY CALIBRATOR LYO 12x5 MICROALBUMIN CALIBRATOR LRTU 5x1x1 PROTEIN STANDARD LRTU 5x1x1 RF CALIBRATOR LRTU 5x1x1 stfr CALIBRATOR LYO 6x1x1 stfr CONTROL LYO 2x3x1 Notes: 1. LYO indicates freeze-dried materials, to give the indicated volume after reconstitution. LRTU indicates materials liquid, ready to use. 2. Calibration materials have assigned values traceable to International Reference Materials, where available, or according to Medicon master lot materials. 3. Medicon Calibrators and Control materials are for use with all our reagent lines, so assigned values are indicated for each instrument line. 4. For constituents and assigned values please refer to Ver. 2 Page 13 of 14

14 Bulk reagents for OEM packaging Our reagents are available for export in bulk form, for further OEM processing. Bulk products are shipped as Raw materials for further processing, not as In vitro diagnostic reagents for testing human samples. Packaging materials: 1Lt Nalgene and/or COEX bottles, 20Lt and 5Lt Qubitainer pouches, optionally customer vials. All packaging materials are certified for use with clinical chemistry reagents. Bulk reagents may be of our standard production, or according to the specific performance requirements of the buyer, as set under special agreement. Before batch release, bulk reagents are tested for quality and performance against specifications under the same rigorous protocol used for our own branded reagents. QC results for each batch will be made available to the buyer, as obtained by testing on certain types of automated discrete chemistry analyzers, solely according to our own internal QC procedures for release of products. We will also provide testing data for regulatory purposes, however all final packaging, QC, certification, registration, and marketing actions will be the responsibility of the buyer. MSDS documents will be provided for each item upon request. Packaging and/or specifications may change without previous notice. For further information please contact the Exports department at MEDICON HELLAS SA 5-7 Melitona st., Gerakas, Attiki, Greece - Tel.: FAX: diag@mediconsa.com, Ver. 2 Page 14 of 14