FDA 510(k)

Simplexa COVID-19 直接检测

K号: K212147 · 2022-09-13

决定日期2022-09-13

产品代码QQX

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决定实质等同

器械摘要

Simplexa COVID-19 Direct 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 2022-09-13 under 510(k) number K212147. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Simplexa COVID-19 Direct?

Simplexa COVID-19 Direct is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K212147.

When did Simplexa COVID-19 Direct receive FDA 510(k) clearance?

Simplexa COVID-19 Direct received FDA 510(k) clearance on 2022-09-13, under 510(k) number K212147.

Who is the listed applicant for Simplexa COVID-19 Direct?

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 Simplexa COVID-19 Direct?

The FDA product code for Simplexa COVID-19 Direct is QQX.

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 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 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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