§864.5700. Automated platelet aggregation system.
21 C.F.R. § 864.5700
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60602, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60602, Sept. 12, 1980]