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e-CFR data is current as of July 1, 2020

Title 21Chapter ISubchapter HPart 864Subpart H → §864.7320


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages


§864.7320   Fibrinogen/fibrin degradation products assay.

(a) Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

(b) Classification. Class II (performance standards).

[45 FR 60615, Sept. 12, 1980]

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