FDA 510(k)

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

Número K: K240867 · 2025-02-11

Data da decisão2025-02-11

Código do produtoQQX

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems 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 2025-02-11 under 510(k) number K240867. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems?

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K240867.

When did cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems receive FDA 510(k) clearance?

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems received FDA 510(k) clearance on 2025-02-11, under 510(k) number K240867.

Who is the listed applicant for cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems?

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® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems?

The FDA product code for cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is QQX.

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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 K253756cobas liat CT/NG nucleic acid test K253759cobas liat CT/NG/MG nucleic acid test

Ver todos os 36 dispositivos →

Dispositivos Relacionados (Código: QQX)

K243396Aptima SARS-CoV-2 AssayHologic, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular K233453Kit de Diagnóstico PCR COVID-19 TaqPath™ da Applied Biosystems™Life Technologies Corporation K230440Xpert® Xpress CoV-2 plusCepheid®K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.

Fonte oficial

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