21 CFR 864.9700
§ 864.9700 Blood storage refrigerator and blood storage freezer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9700, § 864.9700 Blood storage refrigerator and blood storage freezer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89428
- Permanent ID
ys:prov:89428@1- SHA-256
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Full text
(a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
(b) Classification. Class II (special 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.