Profile: Germaine Laboratories, Inc. manufactures & supplies medical diagnostic tests for professional use, point-of-care and over-the-counter consumer use. We offer FDA regulatory consultation and 510k clinical trials.

The company is ISO 13485:2003 certified.

FDA Registration Number: 1649661

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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.

• 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.

• Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB / 862.1115) A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

• Brucella Abortus Antigen

• Brucella Abortus Antiserum

• Brucella Melitensis Antigen

• Brucella Spp Agglutination Antigen (FDA Code: GSO / 866.3085)

• Brucella Spp Fluorescent Antisera (FDA Code: GSM / 866.3085)

• Brucella Suis Antigen

• C-Reactive Protein Test System (FDA Code: DCN / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• 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.

• Clinical Refractometer (FDA Code: JRE / 862.2800) A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

• 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.

• Disinfectant Residuals for Dialysate Reagent Test Strip (FDA Code: MSY / 876.5665) A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

• Drug Testing Kits

• Febrile Antigens Slide/Tube Test (FDA Code: GNC / 866.3550)

• Francisella Tularensis Antiserum Test (FDA Code: GSK / 866.3280)

• Francisella Tularensis Slide and Tube Antigen Test (FDA Code: GSL / 866.3280)

• 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)

• 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.

• 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.

• 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.

• Non-Quantitative Urobilinogen Test (FDA Code: CDM / 862.1785) A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

• Non-Treponemal Antigen (FDA Code: GMQ / 866.3820)

• Occult Blood in Urine Test (FDA Code: JIO / 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.)

• Occult Blood Reagent (FDA Code: KHE / 864.6550)

• 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.

• Oral Fluid Screening Device

• Ovulation (Luteinizing Hormone) Test Kits

• Ovulation Test

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)

• Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN / 866.3085)

• 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.

• Proteus Spp Fluorescent Antisera (FDA Code: GSY / 866.3410)

• Rheumatoid Factor Test System (FDA Code: DHR / 866.5775) A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

• Salmonella Spp Antigen (FDA Code: GRL / 866.3550)

• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550)

• Sensitive Pregnancy Tests

• Serum Human Chorionic Gonadotropin Test (FDA Code: DHA / 862.1155)

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

• Swabs, Streptococcus Test Kits

• Tetrahydrocannabinol Test (FDA Code: DKE / 862.3870)

• 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.

• Urinalysis Test

• Urinary Enzymatic Method (FDA Code: JIL / 862.1340) A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

• Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435) A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.