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FDA 510(k)

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

K-Number: K243400 · 2025-04-25

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-04-25
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-04-25 under approval number K243400. 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 liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test?

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K243400.

When was cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test approved by the FDA?

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test received FDA 510(k) clearance on 2025-04-25, under approval number K243400.

What company makes cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test?

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test?

The FDA product code for cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is QOF.

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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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