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U.S. FDA Medical Device Yeast Identification Kit Requirements


FDA Medical Device Definition: A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Registrar Corp assists Yeast Identification Kit companies with:

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