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U.S. FDA Medical Device Complement Reagent Requirements

FDA Medical Device Definition: A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

Registrar Corp assists Complement Reagent companies with:

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