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

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