21 CFR § 864.7320 - Fibrinogen/fibrin degradation products assay.

---
identifier: "/us/cfr/t21/s864.7320"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7320 - Fibrinogen/fibrin degradation products assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7320"
section_name: "Fibrinogen/fibrin degradation products assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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]