FDA 510(k)

LIAISON NES A组链球菌；LIAISON NES A组链球菌控制拭子套件

K号: K260333 · 2026-06-15

决定日期2026-06-15

产品代码PGX

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决定实质等同

器械摘要

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit 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 2026-06-15 under 510(k) number K260333. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K260333.

When did LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit receive FDA 510(k) clearance?

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260333.

Who is the listed applicant for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

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 Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

The FDA product code for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is PGX.

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。

K251978LIAISON NES 流感A/B，RSV & COVID-19 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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。