CARE ABOUT YOUR HEALTH

Transcription

1 WE CARE ABOUT YOUR HEALTH

2

3 THE REVOLUTION OF MEDICINE DO IT YOURSELF

4 US FDA 510(k)OTC Cleared/Exempt CLIA Waived FERTILITY TESTS SPEED ACCURACY EXCELLENCE HCG PREGNANCY TEST HLH OVULATION TEST* HFSH MENOPAUSE TEST* Simple, One-Step Tests Over 99% Accurate Multiple Test Formats Room Temperature Storage *510(k) Exempt DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

5 SPECIMEN Urine Serum FERTILITY TESTS Pregnancy, Ovulation, Menopause Specimen: Urine / Serum Test Formats: Dip Stick / Midstream Card / Cassette REGISTRATION STATUS PRODUCT DESCRIPTION FORMAT SPECIMEN SENSITIVITY mlu/ml 510(k) Professionnal Forensic / Research hcg hcg II Pregnancy Dip Stick Cassette Urine Midstream Card 25 OTC Self Testing Dip Stick Cassette Urine Cassette Sérum 10 hlh Ovulation Dip Stick Midstream Card Cassette Urine 20 OTC Exempt hfsh Dip Stick Menopause Midstream Card Urine 40 Cassette Exempt OTC Exempt Exempt Intended use hcg The Pregnancy test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hcg) in human urine/serum for the detection of early pregnancy. Intended use hlh The Ovulation Predicting test is a qualitative immunoassay for the detection of human luteinizing hormone (hlh) in human urine to predict the occurence of ovulation. Intended use hfsh The Menopause test is a qualitative immonoassay designed to detect human follicle stimulating hormone (hfsh) in human urine. MADE IN THE USA

6 HEALTH TEST TOTAL CHOLESTEROL SPEED ACCURACY EXCELLENCE US FDA 510(k) OTC Cleared External Use Total Cholesterol Screening Results in 3-5 minutes Up to 98% accurate Easy to use Results between mg mg/dl ( mmol/l) DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

7 SPECIMEN Whole Blood HEALTH TEST TOTAL CHOLESTEROL Specimen: Whole Blood Test Format: Cassette REGISTRATION STATUS PRODUCT DESCRIPTION FORMAT SPECIMEN SENSITIVITY mg/dl 510 (k) PROFESSIONAL Total Cholesterol Pathogenesis of Atherosclerosis and Coronary artery disease Cassette Whole Blood mg/dl Intended use - Total Cholesterol Test The Total Cholesterol Test is intended for in-vitro diagnostics for the semi-quantitative determination of Total Cholesterol in whole blood. The Total Cholesterol Test is used to screen for elevated cholesterol as a risk factor in coronary artery disease. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test provides preliminary analytical results. All results indicating elevated blood cholesterol levels should be verified by a confirmatory method. Clinical considerations and professional judgment should be applied to the interpretation of results by this test. MADE IN THE USA

8 DRUG TEST - SALIVA SPEED ACCURACY EXCELLENCE Results in 5-7 minutes Test Up to 9 Drugs at Once Accuracy Up to 99% accurate Detects Parent THC at 50 ng/ml Minimal Sample Required Easy Collection Method Slim, Ergonomic Device Design DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

9 DRUG TEST - SALIVA SPECIMEN Saliva UP TO 9 ANALYTES IN ONE TEST Product Format Saliva Card Product Registration Status Drug Analyte Choices PRODUCT DESCRIPTION SENSITIVITY (ng/ml) 1 STRIP SINGLE TEST THC Marijuana 50 2 STRIPS IN MULTIPLE TESTS 6 IN 1 AMP Amphetamine 50 Forensic / Research MET XTC COC OPI THC Methamphetamine 50 Ecstasy / MDMA 50 Cocaine 20 Opiates 40 Marijuana 50 2 STRIPS IN MULTIPLE TESTS - 7 IN 1 AMP MET XTC BZD COC OPI THC Amphetamine 50 Methamphetamine 50 Ecstasy / MDMA 50 Benzodiazepine 20 Cocaine 20 Opiates 40 Marijuana 50 2 STRIPS MULTIPLE TESTS 9 IN 1 MADE IN THE USA AMP MET XTC BZD COC OPI MTD PCP THC Amphetamine 50 Methamphetamine 50 Ecstasy / MDMA 50 Benzodiazepine 20 Cocaine 20 Opiates 40 Methadone 20 Phencyclidine 10 Marijuana 50

10 US FDA 510 (k) Cleared HEALTH TEST BLOOD GLUCOSE External Use SPEED ACCURACY EXCELLENCE Blood Glucose Screening Results in 3-5 minutes Up to 98% accurate Easy to use Results between mg/dl DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

11 SPECIMEN Whole Blood HEALTH TEST BLOOD GLUCOSE Specimen: Whole Blood Test Format: Cassette REGISTRATION STATUS PRODUCT DESCRIPTION FORMAT SPECIMEN SENSITIVITY mg/dl 510 (k) PROFFESIONAL Blood Glucose Blood Glucose Measurment Cassette Whole Blood mg/dl Intended use: The blood glucose Test is intended for in-vitro diagnostics for quantitative determination total amount of the Glucose in whole blood. Limitations of procedure The procedure is free from interference if fresh whole blood is used. The Blood Glucose Test is designed for whole blood glucose measurement and should only be compared to the results of other whole blood glucose methods. Methods, which employ only serum or plasma, generally give results which are higher than the whole blood results. The test zone is specific for D-Glucose. Other sugars which may also be present in the blood will not react. Reducing substances such us Uric Acid, Ascorbic Acid, and other which occur in physiological blood concentrations will not affect the reaction. Elevated Cholesterol, Triglycerides and other Lipids which sometimes affect other strips, do not interfere with the Blood Glucose Test. Blood must be analyzed within 30 minutes of collection in order to avoid the effects of glycolysis. The Blood Glucose Test is not recommended for use with neonatal blood specimens. MADE IN THE USA

12 DRUG TEST SPEED ACCURACY EXCELLENCE US FDA 510(k) OTC Cleared, CLIA Waived Test Up to 14 Drugs at Once Accuracy Up to 99.8% Accurate State-of-the-Art Design DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

13 DRUG TEST SPECIMEN Urine UP TO 14 ANALYTES IN ONE TEST Drug Analyte Choices PRODUCT DESCRIPTION SENSITIVITY (ng/ml) Adulteration Controls Available Product Formats Dip Stick, Dip Card, Cassette, Cup Product Registration Status: US FDA Professional / OTC 510(k) Cleared CLIA Waived Forensic / Research AMP AMP300 BAR BZD BUP COC COC150 MET MET300 MET500 MOR MOR/300 MTD OXY OXY100 PCP PPX TCA THC XTC Amphetamine 1000 Amphetamine 300 Barbiturate 200 Benzodiazepine 300 Buprenorphine 10 Cocaine 300 Cocaine 150 Methamphetamine 1000 Methamphetamine 300 Methamphetamine 500 Morphine/Opiate Metabolite 2000 Morphine/Opiate Metabolite 300 Methadone 300 Oxycodone 300 Oxycodone 100 Phencyclidine 25 Propoxyphene 300 Tricyclic Antidepressants 1000 Marijuana 50 Ecstasy / MDMA 500 FORENSIC RESEARCH ONLY CARRIED OUT IN THE USA MADE IN THE USA EDDP FTL K2 KET TRA Methadone Metabolite 100 Fentanyl 200 Synthetic Marijuana 50 Ketamine 1000 Tramadol 200

14 US FDA 510(k) OTC Cleared, CLIA Waived HEALTH TEST COLORECTAL CANCER SPEED ACCURACY EXCELLENCE FOB (FECAL OCCULT BLOOD) TEST GI screen bleeding Colorectal cancer screen Results in 5-10 minutes Up to 98% Accurate Easy-to-use collection tube No dietary restrictions DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

15 SPECIMEN Fecal Matter HEALTH TEST COLORECTAL CANCER Specimen: Fecal Matter Test Format: Cassette REGISTRATION STATUS PRODUCT DESCRIPTION FORMAT SPECIMEN SENSITIVITY mlu/ml 510(k) Professional Forensic / Research FOB Fecal Occult Blood Cassette Fecal Matter 50 OTC Intended use FOB The FOB rapid test is an immunochemical device intended for the qualitative detection of fecal occult blood. It is useful in determining gastrointestinal (GI) bleeding found in a number of gastrointestinal disorders, such as: divirticulitis, colitis, polyps, and colorectal cancer. This test is recommended for use in: Routine physical examinations or when hospital patients are first admitted. Hospital monitoring for GI bleeding in patients. Screening for colorectal cancer or gastrointestinal bleeding. MADE IN THE USA

16 HEALTH TEST INFECTIOUS DISEASE US FDA 510(k) Cleared CLIA Waived (Whole Blood Only) SPEED ACCURACY EXCELLENCE H. (HELICOBACTOR) PYLORI TEST Over 95.1% Sensitive Over 92.8% Specific Fast Results in 4-7 minutes Room Temperature Storage Specific for Toxic Strains Strep A Mononucleosis Helicobacter Pylori Influenza A Influenza B Influenza A & B Hepatitis B 5VHC Dengue HIV 1+2 Malaria Tuberculosis Syphilis Cholera DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

17 SPECIMEN Serum Whole Blood HEALTH TEST INFECTIOUS DISEASE Gastrointestinal Disorder Specimen: Serum / Whole Blood Test Format: Cassette REGISTRATION STATUS PRODUCT DESCRIPTION FORMAT SPECIMEN SENSITIVITY mlu/ml 510(k) Professional Forensic Research H.PYLORI Helicobacter pylori Cassette Serum Serum Whole blood Toxic Strains Intended use H. pylori The H. pylori test is a raid lateral flow, qualitative immunoassay. It is intended to detect the presence of antibodies against Helicobacter pylori in human blood or serum. MADE IN THE USA

18 US FDA 510 (k) Cleared HEALTH TEST CARDIAC MARKERS SPEED ACCURACY EXCELLENCE TNI (TROPONIN I) TEST CARDIAC 3 IN 1 TEST Aids in diagnosis of AMI Results in 15 minutes Up to 94% accurate DEVELOPED & MANUFACTURED IN THE USA US FDA REGULATED * ISO CERTIFIED

19 SPECIMEN Serum Whole Blood HEALTH TEST CARDIAC MARKERS TNI (Troponin I) Cardiac 3 in 1 test Specimen: Serum / Whole Blood Test Format: Cassette REGISTRATION STATUS PRODUCT DESCRIPTION FORMAT SPECIMEN SENSITIVITY mlu/ml 510(k) Professional Forensic Research TNI Cardiac Troponin I Cassette Serum Serum Whole Blood in 1 TNI, CK-MB MYO Troponin I CK-MB Myoglobin Cassette Serum Whole Blood Intended use TNI The Troponin I test is an immunoassay for the rapid qualitative detection of cardiac troponin I (ctnl) in human whole blood or serum at a cutoff level of 1.5 ng/ml. Intended use 3 in 1 The Cardiac 3 in 1 test is an immunoassay for the rapid qualitative detection of cardiac troponin I (TNI), cretine kinase muscle & brain isoenzyme (CKMB), and myoglobin in human whole blood or serum at or above the designed cutoff concentrations. Measurements of these markers can be useful for the early detection of acute myocardial infarction (AMI) by health professionals. MADE IN THE USA

20 For further information, please contact: gocaretest.com