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.
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.
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