cobas liat SARS-CoV-2 v2 nucleic acid test
K-Number: K243346 · 2025-04-11
ApplicantRoche Molecular Systems, Inc.
Decision Date2025-04-11
Product CodeQWR
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
cobas liat SARS-CoV-2 v2 nucleic acid test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval number K243346. The device is classified under product code QWR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the cobas liat SARS-CoV-2 v2 nucleic acid test?
cobas liat SARS-CoV-2 v2 nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K243346.
When was cobas liat SARS-CoV-2 v2 nucleic acid test approved by the FDA?
cobas liat SARS-CoV-2 v2 nucleic acid test received FDA 510(k) clearance on 2025-04-11, under approval number K243346.
What company makes cobas liat SARS-CoV-2 v2 nucleic acid test?
cobas liat SARS-CoV-2 v2 nucleic acid test is manufactured by Roche Molecular Systems, Inc..
What is the FDA product code for cobas liat SARS-CoV-2 v2 nucleic acid test?
The FDA product code for cobas liat SARS-CoV-2 v2 nucleic acid test is QWR.
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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.