Profile: Calbiotech Inc. offers a wide range of diagnostic products, OEM manufacturing, R&D and method validation. We are accredited with ISO 9002 and ISO 13488 certification. We market a wide range of elisa & rapid test products in the areas of infectious diseases, autoimmune disorders, endocrine markers, tumor markers, thyroid markers, fertility markers and steroid markers. Our EZ-elisa line for infectious diseases and autoimmune disorders utilizes a single procedure to perform more than 60 different tests.

FDA Registration Number: 2090110

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• 11-keto Testosterone EIA Kit

• 17- Dehydroxy Progesterone Testing Set

• Amphetamine ELISA Kit

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Anthrax IgG ELISA Kits

• Anti-Myoglobin Detection Kit

• Barbiturates ELISA Kits

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

• C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD / 862.1135) A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

• Cannabinoids ELISA Kits

• Cocaine Metabolite ELISA Kits

• Creatine Kinase Myoglobin Kit

• CRP Ultra Sensitive ELISA Kits

• Cryptococcus Antigen Enzyme Linked Immunoabsorbent Assay Antigen (FDA Code: MDU / 866.3165)

• Dengue Virus IgG ELISA Kits

• Dengue Virus IgM ELISA Kits

• Detection Kits Myoglobin Detection Kit

• ENA Screen

• Enzymatic Pyruvic Acid (FDA Code: JLT / 862.1655) A pyruvic acid test system is a device intended to measure pyruvic acid (an intermediate compound in the metabolism of carbohydrate) in plasma. Measurements obtained by this device are used in the evaluation of electrolyte metabolism and in the diagnosis and treatment of acid-base and electrolyte disturbances or anoxia (the reduction of oxygen in body tissues).

• Estradiol

• Estradiol ELISA Kit

• Estradiol Kits

• Estradiol Radioimmunoassay Test (FDA Code: CHP / 862.1260) An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

• Estriol Radioimmunoassay Test (FDA Code: CGI / 862.1265) An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

• Estrone Radioimmunoassay Test (FDA Code: CGF / 862.1280) An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

• Fentanyl ELISA Kits

• Flunitrazepam ELISA Kits

• Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ / 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.

• Free Estriol (E3)

• Free Testosterone ELISA Kits

• FSH Chemiluminescent ELISA Kits

• General Purpose Reagent (FDA Code: LDT)

• Guinea Pig Anti-Insulin Detection Kit

• Hormones, Progesterone

• Human Growth Hormone Radioimmunoassay (FDA Code: CFL / 862.1370) A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

• Human Insulin ELISA Kit

• Human Insulin-Specific RIA Kit

• Human Myoglobin ELISA Kits

• Hydroxy Progesterone

• Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP / 862.1405) An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

• In Vitro Test System ELISA HAMA IGG Strip (FDA Code: MLH / 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.

• Insulin

• Insulin Disposable Syringes Kits

• Insulin Growth Factor 1 Testing kit

• Insulin Growth Factor and Binding Proteins III

• Insulin Injection Devices

• Insulin Radioimmunoassay

• Insulin Receptor ELISA Kit

• Insulin, diabetic

• Iso-Insulin EIA Diabetes and Obesity Markers