Orgentec Diagnostika Gmbh

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Contact: Mark Kowal
Web: http://www.orgentec.com
E-Mail:
Address: Carl-Zeiss-Straße 49, Mainz 55129, Germany
Phone: +49-(6131)-9258-0 | Fax: +49-(6131)-9258-58 | Map/Directions >>

Profile: Orgentec Diagnostika Gmbh develops, produces and sells test systems for autoimmune diagnostics. We also offer services in the fields of rheumatology, thrombosis, vasculitis, gastroenterology and diabetes diagnostics. Our products are ELISA, alegria, immunoblot and immunofluorence. Our anti-MCV ELISA detects autoantibodies against mutated citrullinated vimentin, MCV, which is a reliable serological test for rheumatoid arthritis. Our Anti-TG ELISA detects autoantibodies to thyroglobulin in human serum. Our Anti-Histone Elisa is a sensitive test that allows for the quantitative detection of the autoantibodies (IgG class). Our ANA-9-Line is a semi-quantitative membrane-fixed immunoblot used for the detection of autoantibodies against various nuclear antigens.

The company was founded in 1988 and is ISO 13485 certified.

FDA Registration Number: 3003232042
US Agent: N/a / N/a

7 Products/Services (Click for related suppliers)

• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100)

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 866.5660)

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100)

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)

• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660)

• Thyroid Autoantibody Test System (FDA Code: JZO / 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.

• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645)

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.