21 CFR § 864.5700 Hematology and Pathology Devices

§ 864.5700 Automated platelet aggregation system.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.5680 Automated heparin analyzer.§ 864.5800 Automated sedimentation rate device. →