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U.S. FDA Medical Device Mycobacteria Identification 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 Mycobacteria Identification companies with:

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