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U.S. FDA Medical Device Factor Deficiency Test Requirements: Factor Deficiency Test

FDA Medical Device Definition: A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene)

Registrar Corp assists Factor Deficiency Test companies with:

  • FDA Factor Deficiency Test Establishment Registration
  • FDA Factor Deficiency Test Listing
  • FDA Factor Deficiency Test Label Requirements and Exceptions
  • FDA Factor Deficiency Test Import Information
  • FDA Factor Deficiency Test Detentions (Factor Deficiency Test Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Factor Deficiency Test Manufacturers (Factor Deficiency Test Suppliers)
       - Factor Deficiency Test Distributors
       - Factor Deficiency Test Processors
       - Factor Deficiency Test Repackers
       - Factor Deficiency Test Relabelers
       - Factor Deficiency Test Exporters
       - Factor Deficiency Test Importers
For more information about Factor Deficiency Test Medical Devices, simply click below:




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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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