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U.S. FDA Medical Device Blood Cell Diluent Requirements

FDA Medical Device Definition: A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

Registrar Corp assists Blood Cell Diluent companies with:

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