FDA 510(k)

LIAISON NES 流感A/B，RSV & COVID-19

K号: K251978 · 2025-12-23

决定日期2025-12-23

产品代码QOF

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决定实质等同

器械摘要

LIAISON NES FLU A/B, RSV & COVID-19 is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251978. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON NES FLU A/B, RSV & COVID-19?

LIAISON NES FLU A/B, RSV & COVID-19 is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K251978.

When did LIAISON NES FLU A/B, RSV & COVID-19 receive FDA 510(k) clearance?

LIAISON NES FLU A/B, RSV & COVID-19 received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251978.

Who is the listed applicant for LIAISON NES FLU A/B, RSV & COVID-19?

The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON NES FLU A/B, RSV & COVID-19?

The FDA product code for LIAISON NES FLU A/B, RSV & COVID-19 is QOF.

列明Diasorin Molecular, LLC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。

K260333LIAISON NES A组链球菌；LIAISON NES A组链球菌控制拭子套件 K252387Simplexa® COVID-19/流感A/B & RSV 直接检测（MOL4450）；Simplexa® COVID-19/流感A/B & RSV 阳性对照包（MOL4460）K220963Simplexa COVID-19 & 流感 A/B 直接检测 K202755Simplexa 先天性巨细胞病毒直接检测和Simplexa 先天性巨细胞病毒阳性对照包 K212147Simplexa COVID-19 直接检测 K201505Simplexa 流感 A/B & RSV 直接检测 II代，Simplexa 流感 A/B & RSV 阳性对照包

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官方来源

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