21 CFR 864.7525
§ 864.7525 Heparin assay.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.7525, § 864.7525 Heparin assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89383
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Full text
(a) Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
(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.