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PMA de la FDA

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Número de PMA: P150015 · 2021-06-02

SolicitanteRoche Molecular Systems, Inc.
Fecha de decisión2021-06-02
Número PMAP150015
Código de productoMZP
Clase del dispositivoClase 2
Especialidad médicaM
Número de regulación21 CFR 8
Comité asesorMI

Resumen del dispositivo

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus 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 2021-06-02. The device is classified under product code MZP. It was reviewed by the MI advisory panel.

Preguntas frecuentes

What is the Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Roche Molecular Systems, Inc..

When did Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

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 Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

The FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is MZP.

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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.

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