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U.S. FDA Medical Device Pregnenolone Radioimmunoassay Requirements


FDA Medical Device Definition: A pregnenolone test system is a device intended to measure pregnenolone (a precursor in the biosynthesis of the adrenal hormone cortisol and adrenal androgen) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases of the adrenal cortex or the gonads.

Registrar Corp assists Pregnenolone Radioimmunoassay companies with:

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