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U.S. FDA Medical Device Sedimentation Rate Tube Requirements


FDA Medical Device Definition: An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

Registrar Corp assists Sedimentation Rate Tube companies with:

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