21 CFR § 864.5700
Automated platelet aggregation system
June 25, 2020
(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).
[45 FR 60602, Sept. 12, 1980]
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