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U.S. FDA Medical Device Red-Cell Diluting Fluid 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 Red-Cell Diluting Fluid companies with:

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