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U.S. FDA Medical Device Vitamin Assay Culture Media Requirements


FDA Medical Device Definition: A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

Registrar Corp assists Vitamin Assay Culture Media companies with:

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