FDA 510(k)

cobas liat CT/NG nucleic acid test

Número K: K253756 · 2026-05-15

Data da decisão2026-05-15

Código do produtoQEP

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

cobas liat CT/NG 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 2026-05-15 under 510(k) number K253756. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2026-05-15. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K253756.

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

cobas liat CT/NG nucleic acid test received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253756.

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

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

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Outros registros que listam Roche Molecular Systems, Inc. como candidato(a)

K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260021cobas® BV/CV K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems K253759cobas liat CT/NG/MG nucleic acid test K243753cobas liat Bordetella panel nucleic acid test

Ver todos os 36 dispositivos →

Dispositivos Relacionados (Código: QEP)

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.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.K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.

Fonte oficial

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