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U.S. FDA Medical Device Tissue Culture Flask 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 Flask companies with:

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