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FDA 510(k)

Alere NT-proBNP for Alinity i Reagent Kit

K-Number: K241176 · 2025-01-16

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2025-01-16
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alere NT-proBNP for Alinity i Reagent Kit is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K241176. 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 Reagent Kit?

Alere NT-proBNP for Alinity i Reagent Kit is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K241176.

When did Alere NT-proBNP for Alinity i Reagent Kit receive FDA 510(k) clearance?

Alere NT-proBNP for Alinity i Reagent Kit received FDA 510(k) clearance on 2025-01-16, under 510(k) number K241176.

Who is the listed applicant for Alere NT-proBNP for Alinity i Reagent Kit?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Axis-Shield Diagnostics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253539Alere NT-proBNP for Alinity iK233541ARCHITECT Active-B12 (Holotranscobalamin)K183088ADVIA Centaur Erythropoietin (EPO) assayK182012ADVIA Centaur Calcitonin (CALCT) assayK172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayK153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

View all 8 devices →

Related Devices (Code: NBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K232164Access NT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.K223637Elecsys proBNP II, Elecsys proBNP II STATRoche DiagnosticsK210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics

Official Source

View on FDA Database →

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

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