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U.S. FDA Medical Device Support Gels Requirements

FDA Medical Device Definition: A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.

Registrar Corp assists Support Gels companies with:

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