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U.S. FDA Medical Device Estradiol Radioimmunoassay Requirements


FDA Medical Device Definition: An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Registrar Corp assists Estradiol Radioimmunoassay companies with:

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