Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Culture Media Supplement Regulations

U.S. FDA Medical Device Culture Media Supplement Requirements


FDA Medical Device Definition: A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

Registrar Corp assists Culture Media Supplement companies with:

  • FDA Culture Media Supplement Establishment Registration
  • FDA Culture Media Supplement Listing
  • FDA Culture Media Supplement Label Requirements and Exceptions
  • FDA Culture Media Supplement Import Information
  • FDA Culture Media Supplement Detentions (Culture Media Supplement Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Culture Media Supplement Manufacturers (Culture Media Supplement Suppliers)
       - Culture Media Supplement Distributors
       - Culture Media Supplement Processors
       - Culture Media Supplement Repackers
       - Culture Media Supplement Relabelers
       - Culture Media Supplement Exporters
       - Culture Media Supplement Importers
For more information about Culture Media Supplement 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco