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e-CFR data is current as of July 7, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5700


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.

(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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