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U.S. FDA Medical Device Orcein 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 Orcein companies with:

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