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U.S. FDA Medical Device Trypsin Requirements

FDA Medical Device Definition: Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

Registrar Corp assists Trypsin companies with:

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