CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART F—Automated and Semi-Automated Hematology Devices (§864.5200 to §864.5950) > 864.5700—Automated platelet aggregation system.

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).

Code of Federal Regulations

[45 FR 60602, Sept. 12, 1980]