cobas liat CT/NG/MG nucleic acid test
K-Number: K253759 · 2026-05-15
ApplicantRoche Molecular Systems, Inc.
Decision Date2026-05-15
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
cobas liat CT/NG/MG nucleic acid test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2026-05-15 under approval number K253759. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the cobas liat CT/NG/MG nucleic acid test?
cobas liat CT/NG/MG nucleic acid test is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K253759.
When was cobas liat CT/NG/MG nucleic acid test approved by the FDA?
cobas liat CT/NG/MG nucleic acid test received FDA 510(k) clearance on 2026-05-15, under approval number K253759.
What company makes cobas liat CT/NG/MG nucleic acid test?
cobas liat CT/NG/MG nucleic acid test is manufactured by Roche Molecular Systems, Inc..
What is the FDA product code for cobas liat CT/NG/MG nucleic acid test?
The FDA product code for cobas liat CT/NG/MG nucleic acid test is QEP.
Other Devices by Roche Molecular Systems, Inc.
Related Devices (Code: QEP)
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.