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. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.”

Code of Federal Regulations

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

CFR

864.7300—Fibrin monomer paracoagulation test.

Code of Federal Regulations