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U.S. FDA Medical Device Lymphocyte Separation Medium Requirements


FDA Medical Device Definition: A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.

Registrar Corp assists Lymphocyte Separation Medium companies with:

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