21 C.F.R. § 864.7300 Fibrin monomer paracoagulation test.
Title 21 - Food and Drugs
(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.” [45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7300 Fibrin monomer paracoagulation test.