Profile: Euro-Diagnostica Ab develops, manufactures and markets diagnostic kits and reagents for use in medical assessments. We offer products for human diagnostics, clinical immunology, immmunochemistry and microbiology. Our clinical immunology products are primarily concerned with the detection of autoimmune diseases, especially those involving the kidneys, where the body's own antibodies attack tissue or cellular components. Our human diagnostics division focus on autoimmune deficiency and rheumatology. Within these areas, we produce packages of enzyme immuno assays for the diagnosis and monitoring of specific diseases.
The company is ISO 9001:2000, ISO 13485:2003 certified.
FDA Registration Number: 9616003
US Agent: Rene Van De Zande / Emergo Global Representation Llc
Phone: +1-(512)-327-9997 Fax: +1-(512)-327-9998 E-Mail:
14 Products/Services (Click for related suppliers)
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• Anti-Cyclic Citrullinated Peptide (Ccp) Antibodies (FDA Code: NHX / 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. |
• Anti-DNA Indirect Immunofluorescent Solid Phase (FDA Code: KTL / 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). |
• Anti-RNP Antibody (FDA Code: LKO / 866.5100) |
• Anti-SM-Antibody (FDA Code: LKP / 866.5100) |
• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100) |
• 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). |
• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 866.5100) |
• B2 - Glycoprotein I Antibodies Test System (FDA Code: MSV / 866.5660) |
• Control Antigen Antinuclear Antibody (FDA Code: LKJ / 866.5100) |
• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100) |
• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660) |
• Indirect Immunofluorescent Antimitochondrial Antibody Test (FDA Code: DBM / 866.5090) An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver). |
• Indirect Immunofluorescent Multiple Auto Antibody (FDA Code: DBL / 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. |