21 CFR 864.5680
§ 864.5680 Automated heparin analyzer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.5680, § 864.5680 Automated heparin analyzer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89343
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Full text
(a) Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
(b) Classification. Class II (special controls).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.