21 CFR 862.2920 - Plasma viscometer for clinical use.
(a)Identification. 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.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.