21 CFR 862.1117
§ 862.1117 B-type natriuretic peptide test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1117, § 862.1117 B-type natriuretic peptide test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89059
- Permanent ID
ys:prov:89059@1- SHA-256
a68f7e07b04b5566b1abca56ab48b26496778dd8a9334ab9ac3e2e10d871e40d
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Full text
(a) Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.
(b) Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.