Profile: Ameritek U.S.A. specializes in rapid in-vitro immunodiagnostic and clinical reagent tests. We deliver various packaging options for our products. We offer white OEM packaging, our best brand & customized packaging & printing to meet the needs of distributors and customers. Our one step rapid tests include cardiac markers, drugs of abuse, feminine diseases, fertility, infectious diseases, miscellaneous, occult blood, sexual transmitted diseases (STD), tumor markers, urinanalysis strips and urine albumin. Our cardiac marker test includes troponin I serum, or whole blood cassette, myoglobin serum, and CRP semi quantitative serum test.
FDA Registration Number: 3025672
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• Alcohol Saliva Strip |
• 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 Gas Chromatography Test (FDA Code: DOD / 862.3100) |
• 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. |
• Breath/Blood Urea Test (FDA Code: MSQ / 866.3110) |
• 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. |
• Carcinoembryonic Antigen Test System (FDA Code: DHX / 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. |
• Chlamydia DNA Reagents (FDA Code: LSK / 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 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. |
• Drugs of Abuse Multiple Test Kit (FDA Code: MVO) |
• Drugs of Abuse Test Systems (FDA Code: MGX) |
• Femlab Vaginitis Cassette |
• Ferritin (FDA Code: DBF / 866.5340) A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. |
• Ferritin Serum |
• Foreign Body Retrieval Magnets |
• FSH Urine Cassette |
• FSH Urine Strip |
• 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) |
• IgE (Immunoglobulin E) Serum |
• IgE Control (FDA Code: DGC / 866.5510) An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. |
• 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. |
• 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. |
• Metabolites Cotinine Nicotine Test System (FDA Code: MRS / 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. |
• 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. |
• Microorganism Differentiation Strip and Reagent Disc (FDA Code: JTO / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease. |
• Morphine Gas Chromatography Test (FDA Code: DMY / 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. |
• Mycobacterium Tuberculosis Fluorescent Antiserum Test (FDA Code: GRT / 866.3370) |
• Myoglobin (FDA Code: DDR / 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. |
• 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. |
• Obstetric pH Paper (FDA Code: LNW / 862.1550) A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets. |
• 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) |
• Ophthalmic Surgery Instruments, Foreign Body Retrieval Magnets |
• 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. |
• Ovulation (Luteinizing Hormone) Test Kits |
• Prostate Specific Antigen Test (FDA Code: MTG) |
• Rheumatoid Factor Serum |
• 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. |
• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 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). |
• Serum Human Chorionic Gonadotropin Test (FDA Code: DHA / 862.1155) |
• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740) |
• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740) |
• Tetrahydrocannabinol Test (FDA Code: DKE / 862.3870) |
• Thyroid Stimulating Hormone Radioimmunoassay (FDA Code: JLW / 862.1690) A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. |
• Thyroid Stimulation Hormone Serum |