FDA 510(k)

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

K-Number: K241806 · 2025-01-08

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 a medical device manufactured by Life Technologies Corporation. It received FDA 510(k) clearance on 2025-01-08 under approval 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. It is manufactured by Life Technologies Corporation. The 510(k) number is K241806.

When was Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel approved by the FDA?

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

What company makes 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 manufactured by Life Technologies Corporation.

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 PubMed Literature

PMID: 40379501 The FDA's Pivotal Role in Global Therapeutic Product Availability. Clinical therapeutics (2025)

Other Devices by Life Technologies Corporation

K170299Ion PGM Dx System K191030Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer K233453Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit PMA P160045Next generation sequencing oncology panel, somatic or germline variant detection system PMA P240040Next generation sequencing oncology panel, somatic or germline variant detection system

Related Devices (Code: QOF)

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Official Source

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