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U.S. FDA Medical Device Quality Control Slides 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 Quality Control Slides companies with:

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