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U.S. FDA Medical Device Antinuclear Antibody Immunological Test Requirements: Antinuclear Antibody Immunological Test

FDA Medical Device Definition: 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)

Registrar Corp assists Antinuclear Antibody Immunological Test companies with:

  • FDA Antinuclear Antibody Immunological Test Establishment Registration
  • FDA Antinuclear Antibody Immunological Test Listing
  • FDA Antinuclear Antibody Immunological Test Label Requirements and Exceptions
  • FDA Antinuclear Antibody Immunological Test Import Information
  • FDA Antinuclear Antibody Immunological Test Detentions (Antinuclear Antibody Immunological Test Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Antinuclear Antibody Immunological Test Manufacturers (Antinuclear Antibody Immunological Test Suppliers)
       - Antinuclear Antibody Immunological Test Distributors
       - Antinuclear Antibody Immunological Test Processors
       - Antinuclear Antibody Immunological Test Repackers
       - Antinuclear Antibody Immunological Test Relabelers
       - Antinuclear Antibody Immunological Test Exporters
       - Antinuclear Antibody Immunological Test Importers
For more information about Antinuclear Antibody Immunological Test Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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