21 CFR 864.5600

§ 864.5600 Automated hematocrit instrument.

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

Cite this

Citation: 21 CFR 864.5600, § 864.5600 Automated hematocrit instrument, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89341
Permanent ID: ys:prov:89341@1
SHA-256: c3b6159b6430bc7d94f89551da6b679dedcb9df75274f256b75261bbbe970a1f

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Full text

(a) Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). (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.