Profile: Biomerica manufactures and distributes medical diagnostic products for the laboratory, doctor's office & pharmacy use. Our products are used for the detection & monitoring of chronic diseases & certain medical conditions. Our allerquant 14G elisa kit is intended for in vitro quantitative analysis of IgG antibodies to 14 specific food allergens in human serum. Our EZ-HCG(tm) is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.

The company was founded in 1971, has revenues of USD 5-10 Million, has ~30 employees and is ISO, CE certified. OTC:BMRA (SEC Filings)

FDA Registration Number: 2025099

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• Luteinizing Hormone

• 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.

• 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.

• Methadone Test Strip

• 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.

• Methamphetamine Test Strip

• Morphine Card 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.

• Parathyroid Hormone Radioimmunoassay Test (FDA Code: CEW / 862.1545) A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)

• Phencyclidine Test Device

• Phencyclidine Test Strip

• Pregnancy Test Kit

• Product Development, Allergy Test Strips

• 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.

• Radio-Allergen Absorbent (RAST) Test (FDA Code: DHB / 866.5750) A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

• Rapid Midstream Test

• Thyroglobulin (FDA Code: DDC / 866.5870) A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• Thyroglobulin Autoantibody Immunochemical (FDA Code: JNL / 866.5870)

• Thyroid ELISA Kits

• Thyroid Thyroglobulin ELISA Kit

• Total Prostate-Specific Antigen (PSA)

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

• 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.

• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Urine Teststrips