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U.S. FDA Medical Device Tissue Culture Roller Bottle Requirements


FDA Medical Device Definition: Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

Registrar Corp assists Tissue Culture Roller Bottle companies with:

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