21 CFR 864.5260
§ 864.5260 Automated cell-locating device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.5260, § 864.5260 Automated cell-locating device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89335
- Permanent ID
ys:prov:89335@1- SHA-256
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Full text
(a) Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)
(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.