21 CFR 866.5350
§ 866.5350 Fibrinopeptide A immunological test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.5350, § 866.5350 Fibrinopeptide A immunological test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89632
- Permanent ID
ys:prov:89632@1- SHA-256
80ace0e7a5234dac649156200bd61155d20da349944f0417b28113469fabf930
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Full text
(a) Identification. A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may aid in the diagnosis and treatment of certain blood-clotting disorders.
(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.