---
kind: "section"
citation: "21 C.F.R. § 864.5680"
title: "21"
number: "864.5680"
heading: "Automated heparin analyzer."
url: "https://uscodex.org/cfr/21/864.5680"
---

# §864.5680. Automated heparin analyzer.

- (a) **Identification.** An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
- (b) **Classification.** Class II (special controls).

## Notes

### Amendments

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]

### Authority

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

### Amendments

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]