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FDA 510(k)

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

K-Number: K241806 · 2025-01-08

ApplicantLife Technologies Corporation
Decision Date2025-01-08
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Life Technologies Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240040Next generation sequencing oncology panel, somatic or germline variant detection systemPMA P160045Next generation sequencing oncology panel, somatic or germline variant detection systemK233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitK191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic AnalyzerK170299Ion PGM Dx System

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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