21 C.F.R. · Food and Drugs
21 C.F.R. § 864.7525

Heparin assay.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 864.7525 — Heparin assay.

§ 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]

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21 C.F.R. § 864.7525
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The regulatory text of 21 C.F.R. § 864.7525 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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