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U.S. FDA Medical Device Inhibin-A Enzyme Immunoassay 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 Inhibin-A Enzyme Immunoassay companies with:

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