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U.S. FDA Medical Device Erythropoietin Assay Requirements: Erythropoietin Assay

FDA Medical Device Definition: A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia

Registrar Corp assists Erythropoietin Assay companies with:

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

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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