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U.S. FDA Medical Device Estriol Radioimmunoassay Requirements


FDA Medical Device Definition: An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

Registrar Corp assists Estriol Radioimmunoassay companies with:

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