FDA 510(k)

Alere NT-proBNP for Alinity i

K号: K253539 · 2026-02-18

决定日期2026-02-18

产品代码NBC

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Alere NT-proBNP for Alinity i 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 2026-02-18 under 510(k) number K253539. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K253539.

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

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

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

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?

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

列明Axis-Shield Diagnostics, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241176Alere NT-proBNP for Alinity i试剂套装 K233541ARCHITECT Active-B12（全转钴胺素）K172133ADVIA Centaur Active-B12 (全反式钴胺素) (AB12) 测定

官方来源

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