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U.S. FDA Medical Device Gene Expression Profiling Test Requirements: Gene Expression Profiling Test

FDA Medical Device Definition: A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer

Registrar Corp assists Gene Expression Profiling Test companies with:

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