Code of Federal Regulations · Section
§ 864.9285 — Automated Cell-washing Centrifuge For Immuno-hematology
21 C.F.R. § 864.9285
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(a) Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351