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U.S. FDA Medical Device Estrone Radioimmunoassay Requirements


FDA Medical Device Definition: An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

Registrar Corp assists Estrone Radioimmunoassay companies with:

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