Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA IGG Immunoassay Reagent Regulations

U.S. FDA Medical Device IGG Immunoassay Reagent Requirements


FDA Medical Device Definition: An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

Registrar Corp assists IGG Immunoassay Reagent companies with:

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






 
U.S. FDA Regulations:

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


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco