Heparin assay.

21 C.F.R. § 864.7525
in effectEffective: 2024-07-01
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(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).

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