FDA 510(k)

cobas Cdiff nucleic acid test for use on the cobas Liat System

N.º K: K212427 · 2021-10-20

SolicitanteRoche Molecular Systems, Inc.

Fecha de decisión2021-10-20

Código de productoOZN

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

cobas Cdiff nucleic acid test for use on the cobas Liat System 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 2021-10-20 under 510(k) number K212427. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the cobas Cdiff nucleic acid test for use on the cobas Liat System?

cobas Cdiff nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K212427.

When did cobas Cdiff nucleic acid test for use on the cobas Liat System receive FDA 510(k) clearance?

cobas Cdiff nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2021-10-20, under 510(k) number K212427.

Who is the listed applicant for cobas Cdiff nucleic acid test for use on the cobas Liat System?

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 Cdiff nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Cdiff nucleic acid test for use on the cobas Liat System is OZN.

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Otros registros que enlistan a Roche Molecular Systems, Inc. como solicitante

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 K253756cobas liat CT/NG nucleic acid test

Ver todos los 36 dispositivos →

Dispositivos relacionados (Código: OZN)

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)Roche Molecular Systems, Inc.K243730Xpert C. difficile/EpiCepheid®K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, Inc.K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.