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U.S. FDA Medical Device Androsterone Radioimmunoassay Requirements


FDA Medical Device Definition: An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.

Registrar Corp assists Androsterone Radioimmunoassay companies with:

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