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U.S. FDA Medical Device Heparin Assay Requirements: Heparin Assay

FDA Medical Device Definition: A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin)

Registrar Corp assists Heparin Assay companies with:

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