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U.S. FDA Medical Device Enriched Culture Media Requirements

FDA Medical Device Definition: An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Registrar Corp assists Enriched Culture Media companies with:

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