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U.S. FDA Medical Device Diastase Requirements

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

Registrar Corp assists Diastase companies with:

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