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U.S. FDA Medical Device Light Green 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 Light Green companies with:

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