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U.S. FDA Medical Device Blood Volume Chromium-51 Requirements


FDA Medical Device Definition: A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte mass and total blood volume).

Registrar Corp assists Blood Volume Chromium-51 companies with:

  • FDA Blood Volume Chromium-51 Establishment Registration
  • FDA Blood Volume Chromium-51 Listing
  • FDA Blood Volume Chromium-51 Label Requirements and Exceptions
  • FDA Blood Volume Chromium-51 Import Information
  • FDA Blood Volume Chromium-51 Detentions (Blood Volume Chromium-51 Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Blood Volume Chromium-51 Manufacturers (Blood Volume Chromium-51 Suppliers)
       - Blood Volume Chromium-51 Distributors
       - Blood Volume Chromium-51 Processors
       - Blood Volume Chromium-51 Repackers
       - Blood Volume Chromium-51 Relabelers
       - Blood Volume Chromium-51 Exporters
       - Blood Volume Chromium-51 Importers
For more information about Blood Volume Chromium-51 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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