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U.S. FDA Medical Device Tissue Culture Tube Requirements

FDA Medical Device Definition: Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

Registrar Corp assists Tissue Culture Tube companies with:

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