FDA 510(k)

Alere NT-proBNP for Alinity i

K-Number: K253539 · 2026-02-18

Decision Date2026-02-18

Product CodeNBC

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Alere NT-proBNP for Alinity i is a medical device manufactured by Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2026-02-18 under approval number K253539. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alere NT-proBNP for Alinity i?

Alere NT-proBNP for Alinity i is a medical device that received FDA 510(k) clearance on 2026-02-18. It is manufactured by Axis-Shield Diagnostics, Ltd.. The 510(k) number is K253539.

When was Alere NT-proBNP for Alinity i approved by the FDA?

Alere NT-proBNP for Alinity i received FDA 510(k) clearance on 2026-02-18, under approval number K253539.

What company makes Alere NT-proBNP for Alinity i?

Alere NT-proBNP for Alinity i is manufactured by Axis-Shield Diagnostics, Ltd..

What is the FDA product code for Alere NT-proBNP for Alinity i?

The FDA product code for Alere NT-proBNP for Alinity i is NBC.

Other Devices by Axis-Shield Diagnostics, Ltd.

K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay K233541ARCHITECT Active-B12 (Holotranscobalamin) K241176Alere NT-proBNP for Alinity i Reagent Kit

Related Devices (Code: NBC)

K192380ST AIA-PACK BNPFujirebio Diagnostics,Inc. K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc. K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.