---
kind: "section"
citation: "21 C.F.R. § 864.7875"
title: "21"
number: "864.7875"
heading: "Thrombin time test."
url: "https://uscodex.org/cfr/21/864.7875"
---

# §864.7875. Thrombin time test.

- (a) **Identification.** A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60628, Sept. 12, 1980]

### Authority

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

### Amendments

[45 FR 60628, Sept. 12, 1980]