21 CFR 864.5620

§ 864.5620 Automated hemoglobin system.

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

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Citation: 21 CFR 864.5620, § 864.5620 Automated hemoglobin system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89342
Permanent ID: ys:prov:89342@1
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Full text

(a) Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood. (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.