Profile: Princeton BioMeditech Corporation created & introduced an extensive menu of over 70 different diagnostic tests for fertility, infectious diseases, drugs of abuse, tumour markers, cardiac markers and environmental applications, covering a wider range of easy-to-use, rapid diagnostic tests. We are an FDA medical device establishment operating under cGMP & certified under ISO 9000 and ISO 13485. We offer products like cardiac marker, drugs of abuse, infectious disease, fertility, tumor marker, food & environmental & veterinary diagnostics. We distribute our products under the trademarks of BioSign®, BioStrip®, LifeSign®, OvuSign® & AccuSign®, through local & national distributors, through retailers and through partnerships with leading pharmaceutical & medical diagnostic companies.
The company was founded in 1988, has revenues of USD 25-50 Million, has ~100 employees and is ISO 9001, CE certified.
FDA Registration Number: 2246703
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• Alpha-Fetoprotein RIA Test System (FDA Code: KTJ) |
• Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ / 862.3100) An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy. |
• Amphetamine Liquid Chromatography Test (FDA Code: DNI / 862.3100) |
• Bacterial Diagnostic Test |
• Barbiturate Enzyme Immunoassay Test (FDA Code: DIS / 862.3150) A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy. |
• Barbiturate Radioimmunoassay Test (FDA Code: DKN / 862.3150) |
• Benzodiazepine Enzyme Immunoassay Test (FDA Code: JXM / 862.3170) A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy. |
• Campylobacter Pylori (FDA Code: LYR / 866.3110) |
• Cancer Detection Test |
• Cannabinoids Enzyme Immunoassay Test (FDA Code: LDJ / 862.3870) A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use. |
• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid). |
• Clinical Colorimeter (FDA Code: JJQ / 862.2300) A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength. |
• Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO / 862.3250) A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose. |
• Drugs of Abuse Multiple Test Kit (FDA Code: MVO) |
• Drugs Of Abuse Test Kits |
• Drugs of Abuse Test Systems (FDA Code: MGX) |
• Fertility Monitoring Test |
• Fertility Monitors, Pregnancy Test Kits |
• Fitc Myoglobin Antiserum Antigen Control (FDA Code: DEA / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. |
• HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX / 862.1155) A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. |
• Helicobacter pylori Antibody Kits |
• High Pressure Liquid Chromatography for Tricyclic Antidepressant Drugs (FDA Code: LFI / 862.3910) A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy. |
• Home pregnancy test kits, Hcg |
• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155) |
• Infectious Mononucleosis Test System (FDA Code: KTN / 866.5640) An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis. |
• Influenza A and B Testing rapid Influenza Testing |
• Influenza Test |
• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485) A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction. |
• Lyme Disease Test |
• Metamphetamine Thin Layer Chromatography Test (FDA Code: DJC / 862.3610) A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose. |
• Methadone Enzyme Immunoassay Test (FDA Code: DJR / 862.3620) A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment. |
• Methamphetamine Gas Chromatography Test (FDA Code: LAF / 862.3610) |
• Methamphetamine High Pressure Liquid Chromatography Test (FDA Code: LAG / 862.3610) |
• Mononucleosis Antibody (MONO) Test Kits |
• Myocardial Infarction (Heart Attack) Test |
• Nocotine And Nicotine Metabolites Enzyme Immunoassasy (FDA Code: MKU / 862.3220) A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning. |
• Opiates Enzyme Immunoassay Test (FDA Code: DJG / 862.3650) An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy. |
• Phencyclidine Enzyme Immunoassay (FDA Code: LCM) |
• Pregnancy Test Kit |
• Radioimmunoassay Test |
• Rubella CF Antiserum (FDA Code: GOM / 866.3510) Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome). |
• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 866.3510) |
• Semen Analysis Device (FDA Code: MNA) |
• Serum Human Chorionic Gonadotropin Test (FDA Code: DHA / 862.1155) |
• Staphylococcus Spp Fluorescent Antisera (All Types) (FDA Code: GTN / 866.3700) |
• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740) |
• Tetrahydrocannabinol Test (FDA Code: DKE / 862.3870) |
• Total Prostate-Specific Antigen (PSA) |
• Tricyclic Antidepressant Drugs Radioimmunoassay Test (FDA Code: LFG / 862.3910) |
• Tricyclic Antidepressant Drugs U.V. Spectrometry (FDA Code: LFH / 862.3910) |