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

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