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FDA 510(k)

cobas® liat CT/NG nucleic acid test

K-Number: K240217 · 2025-01-17

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-01-17
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas® liat CT/NG nucleic acid test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K240217. 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 nucleic acid test?

cobas® liat CT/NG nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K240217.

When was cobas® liat CT/NG nucleic acid test approved by the FDA?

cobas® liat CT/NG nucleic acid test received FDA 510(k) clearance on 2025-01-17, under approval number K240217.

What company makes cobas® liat CT/NG nucleic acid test?

cobas® liat CT/NG nucleic acid test is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas® liat CT/NG nucleic acid test?

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

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K191352binx health io CT/NG AssayBinx Health, Inc. K190515Aptima Combo 2 Assay (Panther System)Hologic, Inc. K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection KitCepheid K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. DEN180047Aptima Mycoplasma genitalium AssayHologic, Inc. K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, 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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