21 CFR 864.7060
§ 864.7060 Antithrombin III assay.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7060, § 864.7060 Antithrombin III assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89361
- Permanent ID
ys:prov:89361@1- SHA-256
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Full text
(a) Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
(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.