FDA 510(k)

DASH® SARS-CoV-2 & Flu A/B Test

K-Number: K241652 · 2024-12-20

Decision Date2024-12-20

Product CodeQOF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

DASH® SARS-CoV-2 & Flu A/B Test is a medical device manufactured by Nuclein, LLC. It received FDA 510(k) clearance on 2024-12-20 under approval number K241652. 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 DASH® SARS-CoV-2 & Flu A/B Test?

DASH® SARS-CoV-2 & Flu A/B Test is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Nuclein, LLC. The 510(k) number is K241652.

When was DASH® SARS-CoV-2 & Flu A/B Test approved by the FDA?

DASH® SARS-CoV-2 & Flu A/B Test received FDA 510(k) clearance on 2024-12-20, under approval number K241652.

What company makes DASH® SARS-CoV-2 & Flu A/B Test?

DASH® SARS-CoV-2 & Flu A/B Test is manufactured by Nuclein, LLC.

What is the FDA product code for DASH® SARS-CoV-2 & Flu A/B Test?

The FDA product code for DASH® SARS-CoV-2 & Flu A/B Test is QOF.

Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC

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.