Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 864.7525 - Heparin assay.

(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).

[45 FR 60623, Sept. 12, 1980]
authority: 21 U.S.C. 351,360,360c,360e,360j,360
cite as: 21 CFR 864.7525