---
kind: "section"
citation: "21 C.F.R. § 864.7525"
title: "21"
number: "864.7525"
heading: "Heparin assay."
url: "https://uscodex.org/cfr/21/864.7525"
---

# §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).

## Notes

### Amendments

[45 FR 60623, Sept. 12, 1980]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60623, Sept. 12, 1980]