---
kind: "section"
citation: "21 C.F.R. § 864.7275"
title: "21"
number: "864.7275"
heading: "Euglobulin lysis time tests."
url: "https://uscodex.org/cfr/21/864.7275"
---

# §864.7275. Euglobulin lysis time tests.

- (a) **Identification.** A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60612, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]

### Authority

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

### Amendments

[45 FR 60612, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]