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U.S. FDA Medical Device Cultured Animal & Human Cells Requirements


FDA Medical Device Definition: Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

Registrar Corp assists Cultured Animal & Human Cells companies with:

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