21 CFR 864.8165

§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.

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

Cite this

Citation: 21 CFR 864.8165, § 864.8165 Calibrator for hemoglobin or hematocrit measurement, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89397
Permanent ID: ys:prov:89397@1
SHA-256: f9b59be7b97ed77bbfe1a780fd6780b0e89964556759f512a96f24ececd34cf2

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Full text

(a) Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined. (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 the limitations in § 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.