---
kind: "section"
citation: "21 C.F.R. § 864.7300"
title: "21"
number: "864.7300"
heading: "Fibrin monomer paracoagulation test."
url: "https://uscodex.org/cfr/21/864.7300"
---

# §864.7300. Fibrin monomer paracoagulation test.

- (a) **Identification.** A fibrin monomer paracoagulation test is a device used to detect fibrin monomer in the diagnosis of disseminated intravascular coagulation (nonlocalized clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot).
- (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). The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See [§ 864.1(d)](/cfr/21/864.1.md?p=d) for information on obtaining this document.

## Notes

### Amendments

[45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000, 84 FR 71799, Dec. 30, 2019]

### Authority

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

### Amendments

[45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000, 84 FR 71799, Dec. 30, 2019]