21 C.F.R. § 864.5700

Current through September 30, 2024
Section 864.5700 - Automated platelet aggregation system
(a)Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
(b)Classification. Class II (performance standards).

21 C.F.R. §864.5700

45 FR 60602, Sept. 12, 1980