Orasure Technologies Inc.

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Web: http://www.orasure.com
E-Mail:
Address: 220 East First Street, Bethlehem, Pennsylvania 18015, USA
Phone: +1-(610)-882-1820 | Fax: +1-(610)-882-1830 | Map/Directions >>
 
 

Profile: Orasure Technologies Inc. supplies oral-fluid collection devices & in vitro diagnostic assays to the employment, criminal justice, drug treatment, life insurance & public health markets for the detection of abused drugs and the antibodies to HIV. We are an ISO 9000, CE MARK certified company. We offer products like abuse testing, cryosurgery, toxicology, forensics & OTC. Cryosurgery is a simple, effective and safe means of treating a wide variety of these lesions, including warts, actinic keratoses, seborrheic keratoses, skin tags, age spots, condyloma acuminata and molluscum. We develop & market oral specimen collection devices, in vitro diagnostic tests and other medical devices. Our products offer advancements in oral fluid testing & cryosurgery & assay detection systems. We also deal in a portable cryosurgical system for use in point-of-care settings.

The company was founded in 2000, has revenues of USD 50-100 Million, has ~240 employees and is ISO 9000, CE certified. NASDAQ:OSUR (SEC Filings)

FDA Registration Number: 3004142665

31 Products/Services (Click for related suppliers)  
• Alcohol (Ethanol) Saliva Test Kits
• Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method (FDA Code: DIC / 862.3040)
An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
• Alkaline Picrate Creatinine Colorimetric Method (FDA Code: CGX / 862.1225)
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
• 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.
• Automated Urinalysis System (FDA Code: KQO / 862.2900)
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
• 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.
• 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.
• 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.
• 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.
• Continuous Flow Sequential Multiple Chemistry Analyzer (FDA Code: JJC / 862.2150)
A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
• Cryosurgical Unit (FDA Code: GEH / 878.4350)
• Drugs of Abuse Test Systems (FDA Code: MGX)
• Enzyme Immunoassay Test
• Glucose Hexokinase Test (FDA Code: CFR / 862.1345)
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• HIV Antibody Test Kits
• HIV Screening - Western Blot
• Hiv-1 Home Test System (FDA Code: MVZ)
• HIV-1 Test Monitor (FDA Code: MTL)
• HIV-1&2 Saliva Test Kit (FDA Code: MWB)
• Liquid Nitrogen Cryosurgical Units
• 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)
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.
• Nadh Oxidation/Nad Reduction (FDA Code: CKA / 862.1030)
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
• 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)
• Saliva Alcohol Test
• Secondary Calibrator (FDA Code: JIT / 862.1150)
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)
• Sputum Collector
• Sterile Specimen Container (FDA Code: FMH / 864.3250)
A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
• Total Protein Biuret Method (FDA Code: CEK / 862.1635)
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
• Western Blot Test Equipment

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