FDA 510(k)

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

K-Number: K223591 · 2023-07-27

Decision Date2023-07-27

Product CodeQOF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K223591. 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 cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System?

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K223591.

When did cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System receive FDA 510(k) clearance?

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System received FDA 510(k) clearance on 2023-07-27, under 510(k) number K223591.

Who is the listed applicant for cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System?

The FDA product code for cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is QOF.

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Other records listing Roche Molecular Systems, Inc. as applicant

K260021cobas® BV/CV K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems PMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS K253759cobas liat CT/NG/MG nucleic acid test K253756cobas liat CT/NG nucleic acid test PMA P140023Somatic gene mutation detection system

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Related Devices (Code: QOF)

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices Incorporated K252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics Limited K251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLC K250080QIAstat-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.