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U.S. FDA Medical Device Selective Broth Culture Media Requirements


FDA Medical Device Definition: A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Registrar Corp assists Selective Broth Culture Media companies with:

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