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U.S. FDA Medical Device Animal & Human Sera Requirements

FDA Medical Device Definition: Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.

Registrar Corp assists Animal & Human Sera companies with:

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