21 C.F.R. § 864.5700 Automated platelet aggregation system.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5700 Automated platelet aggregation system.
