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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

ApplicantRoche Molecular Systems, Inc.
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 a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2023-07-27 under approval 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. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K223591.

When was cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System approved by the FDA?

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 approval number K223591.

What company makes 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 manufactured by Roche Molecular Systems, Inc..

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.

Related Clinical Trials

NCT06417853 Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) COMPLETED

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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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