21 CFR § 864.7060 - Antithrombin III assay.

---
identifier: "/us/cfr/t21/s864.7060"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7060 - Antithrombin III assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7060"
section_name: "Antithrombin III assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 864.7060 Antithrombin III assay.

(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).

[45 FR 60609, Sept. 12, 1980]