Profile: Epitope Diagnostics Inc. is a developer, manufacturer and marketer of niche ELISA kits. Our products include test kits for tumor/cancer, gastrointestinal disease, cardiovascular disease, infectious disease, autoimmune disease, & streptavidin avidin test kits. Our EDI™ osteocalcin (1-43/49) specific ELISA kit is intended for the quantitative determination of both human osteocalcin (1-43), and osteocalcin (1-49) (also referred to as N-mid osteocalcin) levels in test samples. This test is useful for assessing bone formation or osteoblast activity in patients, with changes in the rate of bone turnover in metabolic bone diseases such as osteoporosis, primary hyperparathyroidism, hyperthyroidism, Paget’s disease, and renal osteodystrophy.
FDA Registration Number: 2032839
26 Products/Services (Click for related suppliers)
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• Adenovirus 1-33 CF Antigen (FDA Code: GOD / 866.3020) Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis). |
• Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.5420) Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. |
• Anti-Gliadin (Ab) |
• Anti-Gliadin (Ab) IgA Kit |
• Anti-Gliadin IgA Assay |
• Anti-Gliadin IgG Assay |
• Cancer Test Kits |
• Diagnostic Rapid Test Kits |
• Diagnostic Test Kits |
• ELISA Kits for Cardiac |
• ELISA/EIA Assays |
• Fecal Occult Blood Test |
• Fecal Occult Blood Test Kits |
• Fecal Occult Blood Testing Kit |
• Giardia Spp. (FDA Code: MHI / 866.3220) |
• Gliadin Antibodies (FDA Code: MST / 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. |
• Hepatitis C Antibodies (HCV) Rapid Test Kit |
• 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. |
• Infectious Disease Test Kits |
• 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.) |
• Osteocalcin Test System (FDA Code: NEO / 862.1050) An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. |
• Rapid Test Kits, Test Kit |
• Rotavirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LIQ / 866.3405) Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity. |
• Thyroglobulin Autoantibody Immunochemical (FDA Code: JNL / 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. |
• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870) |
• Tumor Test Kits |