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Approved for Sale in the USA

CLIA Waved

FDA Approved

Over-The-Counter Approved

FDA Approved for Global Export

FDA OTC and Professional Approved Tests Approvals Key
Pregnancy Cassette 7mm (Large)
Pregnancy Cassette 5mm (Small)
Pregnancy Combo Cassette
Pregnancy Serum Cassette
Pregnancy Strip / Dipstick 3.5mm
Pregnancy Strip 5mm
Pregnancy Combo Strip
Pregnancy Midstream
Menopause Cassette
Menopause Strip
Menopause Midstream
Ovulation Cassette
Ovulation Strip
Ovulation Midstream
Colorectal Cancer Test
Glucose Rapid. No machine Required
Blood Alcohol Test
Drug Tests Approvals Key
Amphetamine (AMP) Dipstick
Barbiturate (BAR) Dipstick
Benzodiazepine (BZD) Dipstick
Cocaine (COC) Dipstick
Marijuana (THC) Dipstick
Methadone (MTD) Dipstick
Methamphetamine (MET) Dipstick
Opiate (OPI) Dipstick
Phencyclidine (PCP) Dipstick
Ecstasy (MDMA) Dipstick
Tricyclic Antidepressant (TCA) Dipstick
Oxycodone (OXY) Dipstick
Amphetamine (AMP) Cassette
Barbiturate (BAR) Cassette
Benzodiazepine (BZD) Cassette
Cocaine (COC) Cassette
Marijuana (THC) Cassette
Methadone (MTD) Cassette
Methamphetamine (MET) Cassette
Opiate (OPI) Cassette
Phencyclidine (PCP) Cassette
Ecstasy (MDMA) Cassette
Tricyclic Antidepressant (TCA) Cassette
2 Panel Multi-Drug Dipstick
3 Panel Multi-Drug Dipstick
4 Panel Multi-Drug Dipstick
5 Panel Multi-Drug Dipstick
6 Panel Multi-Drug Dipstick
8 Panel Multi-Drug Dipstick
10 Panel Multi-Drug Dipstick
2 Panel Multi-Drug Cassette
5 Panel Multi-Drug Cassette
6 Panel Multi-Drug Cassette
10 Panel Multi-Drug Cassette
5 Panel Multi-Drug Cup
6 Panel Multi-Drug Cup
10 Panel Multi-Drug Cup
FDA CLIA Waved Professional Approved Tests Approvals Key
H-Pylori Cassette
Influenza A Cassette
Influenza B Cassette
Influenza A & B Combo Cassette
Fecal Occult Blood (FOB) Cassette
Strep A Cassette
Strep A Strip
Mononucleosis Cassette
FDA Professional Approved Approvals Key
Urinalysis Reagent Strip 1 Test
Urinalysis Reagent Strip 6 Test
Urinalysis Reagent Strip 8 Test
Urinalysis Reagent Strip 10 Test
Urinalysis Reagent Strip 11 Test
Troponin I Cassette (S)
Troponin I Cassette (WB)
HIV 1/2 Cassette
International - Export Only Approved Tests Min Qty Approvals Key
MERS 50,000
TB Cassette (tuberculosis) 10,000
Ebola Whole Blood Rapid Test 10,000
Zika Anti-Body Rapid Test 10,000
Cholera Cassette 10,000
Dengue Cassette 5,000
Malaria Cassette 5,000
HIV 1/2 Cassette 5,000
HBsAG (Hepatitis B Antigen) Cassette 5,000
Hep B Antibody Cassette 5,000
HCV (Hepatitis C) Cassette 5,000
H-Pylori Cassette 5,000
Syphilis Cassette 5,000
Anti-Syphilis Cassette 5,000
Syphilis Strip 5,000
HSV-1 (Herpes Simplex Virus 1) Cassette 5,000
HSV-2 (Herpes Simplex Virus 2) Cassette 5,000
HSV 1 & 2 Cassette 5,000
Gonorrhea Cassette 5,000
Gonorrhea Strip 5,000
Chlamydia Cassette SWAB TEST M or F 5,000
Strep A Cassette 5,000
Strep A Strip 5,000
PSA 1ng 5,000
PSA 4ng 5,000
PSA 1 & 4 5,000
Fecal Occult Blood (FOB) Cassette 5,000
CEA Cassette 5,000
AFP Cassette 5,000
Myoglobin Cassette 5,000
Myoglobin/Troponin Combo Cassette 5,000
CRP: C Reactive Protein Cassette 5,000
My/CRP Combo Cassette 5,000
My/CK-MB/Tri Combo Cassette 5,000
TSH Adult Cassette (thyroid) 5,000
TSH Neonatal Cassette (thyroid) 5,000
IgE Allergy 5,000
NOT FDA Approved for Sale in US

    Wholesale Retail or Distributor Application

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