21 CFR 864.7320
§ 864.7320 Fibrinogen/fibrin degradation products assay.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7320, § 864.7320 Fibrinogen/fibrin degradation products assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89371
- Permanent ID
ys:prov:89371@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.