Blue Earth, Minn. Sofia, Bulgaria United States of America. European Union. IVD Manufacturer

Transcription

1 Blue Earth, Minn. Sofia, Bulgaria United States of America European Union IVD Manufacturer

2 Made in the U.S.A. 1,25 0m ile s( MINNESOTA ) km 12 2,0 Blue Earth MINNESOTA Blue Earth INNOVATIVE PRODUCTS Highly accurate Custom configurations 510(k) cleared Health Canada Class III license CE marked Patented technology First-to-market with rapid urine tests for alcohol, K2/Spice, GHB, and EtG BLUE EARTH, MINN. SINCE 2005 Express Diagnostics Int l (EDI) is the FDA-registered, ISO 13485:2003certified manufacturer of DrugCheck onsite drugs of abuse screening devices. EDI has grown from five employees to 100 since its founding in 2004 and implementation of in-house manufacturing in In recognition of this rapid growth, Inc. magazine recently named EDI to its Inc list of fastest-growing companies in the U.S. for the third consecutive year. The company s combination of toxicology, manufacturing, development, and marketing expertise has helped position Express Diagnostics Int l as a world leader in rapid drug testing. U.S. MANUFACTURING FACILITY ISO 13485:2003 certified FDA cgmp compliant State-of-the-art manufacturing Centrally located in the U.S. Regional offices in California, Iowa, and Massachusetts Worldwide distribution network 2 drugcheck.com CONTRACT MANUFACTURING PRIVATE LABEL RESEARCH and DEVELOPMENT 1550 industrial drive blue earth, mn, usa

3 Made in Europe 25 km km Express Diagnostics Global, Ltd. (EDG), a new subsidiary based in Sofia, Bulgaria, is central to a strategic plan to deliver increased production capacity and enhanced support to distributors in the EMEA region (Europe, the Middle East, Africa). EDG will dedicate manufacturing at its Sofia facility primarily to satisfying EMEA demand for EDI s DrugCheck onsite drugs of abuse screening devices. 40 SOFIA, BULGARIA JANUARY 2016 In addition to the production of rapid drug tests, EDG will offer contract manufacturing and packaging to a wide range of medical products companies, as well as assistance with research and development. EUROPEAN MANUFACTURING FACILITY cgmp compliant State-of-the-art manufacturing Centrally located in the EMEA for cost-effective distribution MEDICAL DEVICE MANUFACTURING CONTRACT MANUFACTURING and PACKAGING PRIVATE LABEL RESEARCH and DEVELOPMENT 3 drugcheck.com 8, iliansko shose street, sofia 1220, bulgaria

4 DRUGS OF ABUSE TESTS DrugCheck is well known in the industry for easy-to-read devices that incorporate single drug, color-coded test strips. All urine test cups, dips, and saliva tests use common color coding for quick recognition of individual drug strips. C T C T C T NXSTEP ONSITE CUP Detects the presence of drug metabolites in minutes. Test for up to 15 drugs, alcohol and/or adulterants in urine. _ NXSCAN ONSITE CUP NEGATIVE (-) POSITIVE (+) INVALID Express Diagnostics offers devices and configurations specifically for the international market, including custom drug cutoffs for urinalysis and saliva. Multiple drugs and cutoffs available cgmp compliant, ISO 13485:2003- certified manufacturer CE certified 50+ AVAILABLE DRUG TESTS AND CUTOFFS Test Strip Drug Urine 510(k) Cleared Urine Health Canada Class III Licensed Urine Forensic Use Only Oral Fluid Forensic Use Only Alcohol 0.02% 0.02% 0.02% Amphetamine , Barbiturate Benzodiazepine Buprenorphine 10 5, 10 5* 5 Cocaine 150, , * 20 Cotinine EDDP EDDP DDP EDDP EDD EDDP/Methadone ETG ETG TG ETG ETG EtG (Ethyl glucuronide) 500 Fentanyl HB GHB GHB GHB GHB GHB GHB GHB GHB G GHB 10 K2/Spice 50 25, 50 ET KET KET Ketamine K2/SPICE K2/SPICE CE K2/SPICE K2/S KET KET Marijuana * 50** MDMA/Ecstasy Methadone * 30 Methamphetamine 500, , Opiates 300, , *, 3500* 40 Oxycodone Phencyclidine Propoxyphene Tramadol * Tricyclic Antidepressants All cutoffs ng/ml except alcohol (BAC) and GHB (µg/ml). * Available by special order only. **Parent drug Detects the presence of drug metabolites in minutes. Test for up to 14 drugs, alcohol and/or adulterants in urine. Flat-panel device to photocopy or scan results. _ DIP CASSETTES Detect up to 14 drugs, alcohol and/or adulterants in urine. Accurate results in 5 minutes. All DrugCheck dip tests are also available in single cassettes or strips. 4 drugcheck.com

5 K2/SPICE TEST SYNTHETIC CANNABIS Screen for 18 compounds Name JWH-018 JWH-018 JWH-018 JWH-018 JWH-019 JWH-019 JWH-073 JWH-073 JWH-073 JWH-122 JWH-122 JWH-200 Compounds Detected by DrugCheck K2 Test N-propanoic acid 5-pentanoic acid metabolite N-4-hydroxypentyl N-5-hydroxypentyl 6-hydroxyhexyl 5-hydroxyhexyl 4-butanoic acid metabolite N-2-hydroxybutyl N-4-hydroxybutyl N-4-hydroxypentyl N-5-hydroxypentyl 6-hydroxyindole Name JWH-210 JWH-398 MAM2201 RCS-4 JWH-081 JWH-250 Picks up more compounds than any other K2 onsite test Compounds Detected by DrugCheck K2 Test N-(5-carboxypentyl) metabolite C 26 H 25 NO 3 N-pentanoic acid metabolite N-pentanoic acid metabolite N-(5-carboxypentyl) metabolite C 21 H 21 NO 4 4-methoxynaphthalen- 1-yl- (1-pentylindol- 3-yl) methanone 2-(2-methoxyphenyl)-1-(1- pentylindol-3-yl)ethanone Most sensitive K2 onsite test: more sensitive than many lab-based tests GAMMA-HYDROXYBUTYRIC ACID (GHB) GHB is a colorless, odorless chemical that has been widely used in drug facilitated sexual assaults and there is an increasing trend of recreational use. The DrugCheck GHB Test, with a patented enzyme, detects the presence of GHB in human urine at concentrations from GHB Color Chart 10 µg/ml to 50 µg/ml. Read initial results at 2 minutes. Test may take up to 10 minutes to detect lower concentrations of GHB near the 10 µg/ml cutoff. Compare color on the 0 µg/ml 10 µg/ml 50 µg/ml test pad to the color chart provided. FORENSIC USE OR EXPORT ONLY ADULTERATION / SPECIMEN VALIDITY Compare the colored pads on reacted strips to color blocks on the Adulterant Color Chart. Adulterated urine will show results similar to those in the Abnormal columns of the color chart; unadulterated samples similar to those in the Normal column. DC294B 1013 Adulterant (specimen validity) pads must be read at Test Read Time below as pad color may change. Pad Order & Test Read Time Pre-Test Color Abnormal (low) Normal Abnormal (high) Creatinine (CR) 45 seconds Nitrite (NI) 45 seconds Glutaraldehyde (GL) 45 seconds ph (ph) Immediate Specific Gravity (SG) 45 seconds Oxidant/Bleach (OX) 30 seconds Adulterant Color Chart 20 Negative mg/dl >15mg/dl Negative Positive 4 > > Negative Positive SALIVASCAN ORAL FLUID DRUG TEST with Sponge Saturation Indicator Sponge Saturation Indicator turns red when sufficient sample has been collected Detects up to 10 drugs simultaneously PATENTED Single drug per strip Detect very recent drug use no waiting for up to days for drug metabolites to appear in donors urine or blood Tamper evident and air tight to retain remaining saliva for laboratory confirmation Magnification windows for clear, definitive results MADE IN THE USA Typical time-determined collection methods are often ineffective when donors are smokers or users of certain prescription drugs, which can cause severe dry mouth. SalivaScan s sponge saturation indicator activates when sufficient sample has been collected. DRUGCHECK SALIVASCAN DRUG TESTS AND CUTOFFS Test Strip Drug Oral Fluid Alcohol 0.02% Amphetamine 50 Barbiturate 50 Benzodiazepine 10 Buprenorphine 5 Cocaine 20 Cotinine 50 EDDP EDDP DDP EDDP EDD EDDP/Methadone 20 KET KET ET KET KET Ketamine 50 EXAMPLE: Presumptive positive alcohol Test Strip Drug Oral Fluid Marijuana 50* Methadone 30 Methamphetamine 50 Opiates 40 Oxycodone 20 Phencyclidine 10 Propoxyphene 50 All cutoffs ng/ml except alcohol (BAC) *Parent drug Saliva Alcohol Color Chart Alcohol strips must be read at 2 minutes as pad color may change. 0% 0.02% 0.04% 0.08% 0.30% GLUTARALDEHYDE AVAILABLE FOR EXAMPLE: Presumptive positive for cocaine 5 drugcheck.com

6 ALCOHOL TESTS: BREATH, SALIVA, URINE FC90 BREATH ALCOHOL TEST (AT578) FC300e BREATH ALCOHOL TEST (AT576) ETG (ETHYL GLUCURONIDE) 48-hour detection time in human urine Fast: Dip test in specimen for 15 seconds Negative results can be read in less than 1 minute, as soon as both test and control lines have formed Read positive results at 5 minutes and up to 2 hours Shelf life of two years from date of manufacture No cross reaction after use of mouthwash or hand sanitizers Patent pending DOT approved and 510(k) cleared for OTC European fuel cell sensor Accuracy: +/-0.005% at 0.05% Memory: 5 records Testing time: 10 seconds Comparable in price to semiconductors but more accurate MOUTHPIECES For use with all AlcoCheck FC90 and FC300e 1 unit (package) = 100 pieces #ATA-010 BREATH ALCOHOL SCREEN 510(k) cleared for OTC Pass/fail design detects alcohol at specific BAC levels Three threshold levels: 0.02%, 0.05%, and 0.08% Plastic tube design allows test to be carried anywhere # 50902K 0.02 AlcoCheck (25 per box) # 50905K 0.05 AlcoCheck (25 per box) # 50908K 0.08 AlcoCheck (25 per box) 510(k) cleared for OTC European fuel cell sensor: 3/4 (19mm) Detect: % Color change of display if above legal limit Accuracy: +/ % at 0.05% Memory: 1000 records Memory download to PC Power: 9V battery or DC 12V OPTIONAL PORTABLE PRINTER AND CASE SALIVA ALCOHOL 510(k) cleared for OTC and CLIA waived Gender-neutral, observed collection Results in 2 minutes Indicates recent alcohol consumption Easy interpretation # URINE ALCOHOL Urine is the most practical specimen for alcohol testing in the workplace, specifically when the purpose of testing is to demonstrate that alcohol consumption has occurred. Peak urine alcohol levels are reached 45 to 60 minutes after alcohol ingestion, when they are typically about 1.3 times greater than the blood alcohol concentration. Alcohol may be detected in urine 1 to 2 hours longer than it is detected in the blood. Available in cup and dip formats. Urine Saliva Negative = 0.0% Positive > 0.02% Alcohol Color Chart Alcohol strips must be read at 2 minutes as pad color may change. 0% 0.02% 0.08% 0.30% DC410C drugcheck.com

7 HEALTH SCREENING PREGCHECK+ EARLY PREGNANCY TEST The PregCheck+ Early Pregnancy Test is designed for the rapid determination of human chorionic gonadotropin (hcg) in human urine/serum, for professional use in obtaining a visual qualitative result for the detection of pregnancy. Specimen is dropped in the sample well of the cassette. Results are read at 3 to 5 minutes. #PC80200 PregCheck+ Urine/ Serum (25 per box) 510(k) cleared URINCHECK HEALTHSCREEN-10 URINE REAGENT STRIPS UTI TEST STRIPS /2015 Urinary tract infection test Clinically tested Tests for leukocytes (white blood cells and nitrite) Rapid, cost-effective alternative to lab testing Results in just 2 minutes! #UTI (k) cleared for OTC and CLIA waived URINCHECK ADT-7 DRUG ADULTERATION TEST HealthScreen-10 is intended to provide semiquantitative determination of glucose, bilirubin, ketone, specific gravity, blood, ph, protein, urobilinogen, nitrite, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriurea. #UC81200 (100 strips per bottle) CLIA waived URINASSIST SPECIMEN COLLECTION AID Effective when assisting children, the elderly, the infirm, and during pregnancy Reduce spillage and contamination of hands, container, and surroundings Save nursing time with simplified patient self-collection Seal is leak-proof once UrinAssist is screwed onto the specimen cup. If the cup overfills, the excess sample can be poured out. UrinCheck ADT-7 is a rapid test for the determination of adulterated urine specimens with tests for creatinine, nitrite, glutaraldehyde, ph, specific gravity, oxidants/bleach, pyridinium chlorochromate. #UC81100 (25 strips per bottle) # UA-800 Kit: UriAid funnel, sterile 90mL cup, towelette, 50/case # UA-850 UriAid funnel only, 100/case 7 drugcheck.com

8 1550 industrial drive, p.o. box 310, blue earth, mn drugcheck.com DC271I 1115