21 CFR 864.9275
§ 864.9275 Blood bank centrifuge for in vitro diagnostic use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9275, § 864.9275 Blood bank centrifuge for in vitro diagnostic use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89419
- Permanent ID
ys:prov:89419@1- SHA-256
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Full text
(a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.