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U.S. FDA Medical Device Trichomonas Screening 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 Trichomonas Screening Kit companies with:

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