FDA APPROVED BIOTRON DIAGNOSTICS PRODUCT LIST
The following products are manfactured/distributed by BioTron Diagnostics USA,
and have been approved by the F.D.A. Our F.D.A. permit number is 1824721.
SEROFAST SEROLOGICAL KITS
Antistreptolysin -O (ASO) RPR (Rapid Card Test for Detection of Syphillis)
Infectious Mononucleosis ( IM)) RPR Controls
Systematic Lupus Erthematosus (SLE) Anti-Nuclear Antibodies assoc.with SLE (ANA)
C-Reactive Protein (CRP) Rheumatoid Factor ( RF/RA)
FOREMOST PREGNANCY TEST KITS
Direct Pregnancy Test (Monoclonal) Indirect Pregnancy Test (Monoclonal)
Visual HCG Pregnancy Test Visual Pregnancy Test
One-Step Pregnancy Urine Card Test One Step Pregnancy Urine Dipstick Test
One Step Pregnancy Urine/Serum Card Test One Step Pregnancy Urine/Serum Dipstick Test
Midstream Home Pregnancy Test One Pregnancy Test (OTC)
FOREMOST FERTILITY TEST KITS
One Step LH Ovulation Card Test One Step LH Ovulation Dipstick Test
UROFAST URINE REAGENT STRIPS
Urine Reagent Strip - 1 parameter Urine Reagent Strip - 2 parameters
Urine Reagent Strip - 3 parameters Urine Reagent Strip - 4 parameters
Urine Reagent Strip - 8 parameters Urine Reagent Strip - 5 parameters
Urine Reagent Strip - 9 parameters Urine Reagent Strip - 6 parameters
Urine Reagent Strip - 10 parameters Urine Reagent Strip - 7 parameters
HEMOFAST BLOOD GLUCOSE REAGENT STRIPS
GlucoCheck Glucose Strip
BIOFAST DRUG SCREENING TEST KITS
One Step Cocaine Test One Step Marijuana Test
One Step Morphine Test One Step Amphetamine Test
One Step Methamphetamine Test One Step BZD Test
One Step Barbiturates Test One Step Methadone Test
One Step Phencyclidine Test One Step Morphine/Opiates Test
One Step COC/THC Test One Step BZD/BAR/PCP Test
One Step COC/THC/OPI Test One Step BAR/BZD/MTD Test
One Step AMP/THC/MOR/BZD Test One Step COC/THC/MOR/AMP/PCP Test
One Step COC/THC/MOR/AMP/ BZD Test One Step AMP/COC/THC/MOR/BZD/MET Test
One - Site MultiDrug Test Kit
RADIOIMMUNOASSAY TEST KITS
Estradiol Direct RIA T3 RIA
Aldosterone Direct RIA T4 RIA
Total Urine/Plasma Estriol RIA TBG RIA
Cortisol RIA T3 UPTAKE RIA
DHEA - S Direct RIA TSH RIA
HPL RIA Progesterone Direct RIA
6 - Keto (prostaglandin F1) Thrombane B RIA
MBP (Mylein Basic Protein) Digoxin RIA
EIA/ELISA TEST KITS
T4 EIA Bead TSH EIA Microtiter
T3 EIA Bead LH EIA Microtiter
TSH EIA Bead FSH EIA Microtiter
Cortisol EIA Bead rolactin EIA Microtiter
T4 EIA Microtiter B HCG EIA Microtiter
T3 EIA Microtiter ANA EIA Microtiter
IMMUNOFAST RAPID TEST KITS
Rubella Card Test Infectious Mono Card Test
Strep A Card Test Infectious Mono WB Test
Myoglobin - Cardiac Test CK - MB - Cardiac Test
Trponin 1 - Cardiac Test Helicobacter Pylori - Cancer Marker
Fecal Occult Blood - Cancer Marker *PSA - Cancer Marker (* - pending)
BIOFAST BLOOD BANK REAGENTS
BLOOD GROUPS: FEBRIL ANTIGENS:
Blood Grouping Anti-A Brucella Abortus
Blood Grouping Anti-B Proteus OX19
Blood Grouping Anti-A&B Salmonella O Group A Antigen
Blood Grouping Anti-D Salmonella O Group B Antigen
Salmonella O Group C Antigen
Salmonella O Group D Antigen
FASTCHEM - CLINICAL CHEMISTRY TEST KITS
Acid Phosphatase (color) CK - MB
Acid Phosphatase (kinetic) y - Glutamyl Transferase
Albumin Glucose Hexokinase
Alkaline Phosphatase (kinetic) Glucose Oxidase
Alkaline Phosphatase (color) Glucose Liquid
ALT (kinetic) Glycohemoglobin
ALT (color) HBDH (kinetic)
Ammonia HDL Cholesterol
Amylase (kinetic) Hemoglobin
Amylase (color) Iron/TIBC
AST (kinetic) Inorganic Phosphorous (color)
AST (color) Inorganic Phosphorous (kinetic)
BILE ACIDS LDH (color)
Bilirubin (Direct) LDH (kinetic)
Bilirubin (Total) Lipase (turbidimetric)
BUN (kinetic) Lipase (collipase, Rate)
BUN (color) Magnesium
Calcium CSF/Urine Total Protein
Carbon Dioxide Potassium
Cholesterol Sickle Cell Reagent Set
Cholerstrol Liquid Sodium
Choline Esterase (kinetic) Total Protein
Chloride Triglyceride, INT
Creatinine (color) Triglyceride, GPO
Creatinine (kinetic) Uric Acid
Creatinine Kinase (color) Uric Acid Liquid
Creatinine Kinase NAC (color) CK - MB Control
Creatinine Phosphokinase Glycohemoglobin Control
Registeration number and location of manufacturing/distribution
site in the U.S.A.
Registeration number: 1824721