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U.S. FDA Medical Device Antithrombin III Assay Requirements: Antithrombin III Assay

FDA Medical Device Definition: An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III)

Registrar Corp assists Antithrombin III Assay companies with:

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




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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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