§ 864.7525. Heparin assay.
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/us/cfr/t21/s§ 864.7525·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]