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U.S. FDA Medical Device Plasma Viscometer Requirements

FDA Medical Device Definition: A plasma viscometer for clinical use is a device intended to measure the viscosity of plasma by determining the time period required for the plasma to flow a measured distance through a calibrated glass tube. Measurements obtained by this device are used to monitor changes in the amount of solids present in plasma in various disorders.

Registrar Corp assists Plasma Viscometer companies with:

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