21 CFR 864.9285

§ 864.9285 Automated cell-washing centrifuge for immuno-hematology.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 864.9285, § 864.9285 Automated cell-washing centrifuge for immuno-hematology, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89420
Permanent ID: ys:prov:89420@1
SHA-256: df03ac3e7e0a9b84ffff29d355e13870e53c3a90c5fe369a10ad55db688bad80

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Full text

(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.