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U.S. FDA Medical Device Potentiating Media Requirements

FDA Medical Device Definition: Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

Registrar Corp assists Potentiating Media companies with:

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