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U.S. FDA Medical Device Anaerobic 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 Anaerobic Identification Kit companies with:

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