Triage B-Type Natriuretic Peptide (Bnp) Test

by Biosite Incorporated 2 variants

De Novo DEN000010

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

in data synced 10 Oct 2026

Documents

De Novo DEN000010↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Post-NSE	NumberDEN000010	Date20 Nov 2000Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number: DEN000010
FDA Product Code: NBC

Device Class: Class II
Regulation: 21 CFR Part 862.1117
Advisory Committee: Clinical Chemistry
FDA Decision: DENG De Novo granted

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