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U.S. FDA Medical Device Aniline Requirements

FDA Medical Device Definition: Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Registrar Corp assists Aniline companies with:

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