21 CFR 864.9225
§ 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9225, § 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89417
- Permanent ID
ys:prov:89417@1- SHA-256
ec335de9569007852b66299156b2e1e88843ff5527392d0d60eae1431ab14200
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Full text
(a) Identification. Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.
(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.