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FDA 510(k)

cobas® liat CT/NG/MG nucleic acid test

K-Number: K240197 · 2025-01-16

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-01-16
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas® liat CT/NG/MG nucleic acid test 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 2025-01-16 under 510(k) number K240197. 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 2025-01-16. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K240197.

When did cobas® liat CT/NG/MG nucleic acid test receive FDA 510(k) clearance?

cobas® liat CT/NG/MG nucleic acid test received FDA 510(k) clearance on 2025-01-16, under 510(k) number K240197.

Who is the listed applicant for cobas® liat CT/NG/MG nucleic acid test?

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® liat CT/NG/MG nucleic acid test?

The FDA product code for cobas® liat CT/NG/MG nucleic acid test is QEP.

Other records listing Roche Molecular Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260021cobas® BV/CVK260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsPMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK253759cobas liat CT/NG/MG nucleic acid testK253756cobas liat CT/NG nucleic acid testPMA P140023Somatic gene mutation detection system

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Related Devices (Code: QEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.

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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