eCFR Reference Browser

---

title: "21 CFR §864.7300"

source: "https://www.ecfr.gov/current/title-21/section-864.7300"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "864"

part_subject: "HEMATOLOGY AND PATHOLOGY DEVICES"

subpart_code: "H"

subpart_subject: "Hematology Kits and Packages"

section_number: "864.7300"

section_subject: "Fibrin monomer paracoagulation test."

cfr_reference: "21 CFR 864.7300"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.”

§864.7300 - Fibrin monomer paracoagulation test.