Profile: Alfa Scientific Designs, Inc. develops & manufactures quality rapid in-vitro diagnostic devices to serve the point-of-care marketplace including hospitals, physicians, criminal justice & occupational health centers. We concentrate on rapid immunoassays including those for the detection of drugs of abuse, fertility hormones, infectious diseases, cardiac & cancer markers. Our instant-view® barbiturate urine drug test is a one-step, lateral flow test designed to detect barbiturates in human urine at a cut-off level of 200 ng/ml. Barbiturates are central nervous system depressants & are used as hypnotic sedatives. We are accredited with ISO13485:1996 certification.

The company was founded in 1996, has revenues of USD 1-5 Million, has ~50 employees and is ISO 9001, CE certified.

FDA Registration Number: 2060833

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• 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 Urine Dip Strip 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 Urine Cassette Test

• 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.

• Benzodiazepine Urine Cassette Test

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Cancer Marker Tests

• 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.

• Cocaine Urine Dip Strip Test

• Cocaine Urine Drug Test

• Drug Testing Kits

• Drug Testing System

• Drugs Of Abuse Test Kits

• General Diagnostic Supplies

• Goat Antibody Morphine (125-I) Radioimmunoassay Test (FDA Code: DOE / 862.3640) A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

• H. Pylori Serum Cassette Test

• H. Pylori Serum Dip-Strip Test

• 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.

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)

• LH Ovulation Urine Cassette

• 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.

• 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 Urine Cassette Test

• Methamphetamine Urine Dip Strip Test

• Morphine Liquid Chromatography Test (FDA Code: DPK / 862.3640)

• Morphine Urine Dip Strip Test

• Morphine Urine Drug Test

• Multi-Drug Screen Panel Test

• Occult Blood Reagent (FDA Code: KHE / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• 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.

• Over The Counter Benzodiazepine Test (FDA Code: NFV / 862.3170)

• Over The Counter Follicle Stimulating Hormone (Fsh) Test (FDA Code: NGA / 862.1300) A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• Ovulation (Luteinizing Hormone) Test Kits

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)

• Phencyclidine Urine Cassette Test

• Phencyclidine Urine Dip Strip Test

• Propoxyphene Enzyme Immunoassay (FDA Code: JXN / 862.3700) A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

• Propoxyphene Urine Drug Test

• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 866.6010) A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

• Serum Cassette Test

• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740)

• TCA Urine Drug Test

• Tetrahydrocannabinol Test (FDA Code: DKE / 862.3870)

• Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (FDA Code: MLK / 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.

• Tricyclic Antidepressant Drugs Radioimmunoassay Test (FDA Code: LFG / 862.3910)

• Troponin Subunit Enzymatic Method (FDA Code: MMI / 862.1215) A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.