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U.S. FDA Medical Device Globulin Electrophoretic Requirements


FDA Medical Device Definition: A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

Registrar Corp assists Globulin Electrophoretic companies with:

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