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).

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