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Notes

§864.5700. Automated platelet aggregation system.

21 C.F.R. § 864.5700

(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).
Notes, amendments, and revision history

Amendments

[45 FR 60602, Sept. 12, 1980]

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Amendments

[45 FR 60602, Sept. 12, 1980]