FDA 510(k)

应用生物系统™ TaqPath™ COVID-19、流感A、流感B、RSV选择面板

K号: K241806 · 2025-01-08

决定日期2025-01-08

产品代码QOF

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决定实质等同

器械摘要

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel is the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies Corporation. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K241806. 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 Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel?

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Life Technologies Corporation. The 510(k) number is K241806.

When did Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel receive FDA 510(k) clearance?

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel received FDA 510(k) clearance on 2025-01-08, under 510(k) number K241806.

Who is the listed applicant for Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel?

The FDA 510(k) record lists Life Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel?

The FDA product code for Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel is QOF.

列明Life Technologies Corporation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。

K233453应用生物系统™ TaqPath™ COVID-19诊断PCR套件 K191030应用生物系统™ 3500 Dx遗传分析仪和应用生物系统™ 3500xL Dx遗传分析仪 K170299离子PGM Dx系统

官方来源

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