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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: P020011 · 2020-07-21

SolicitanteGen-Probe
Fecha de decisión2020-07-21
Número PMAP020011
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 Gen-Probe. It received FDA 510(k) clearance on 2020-07-21. 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 2020-07-21. The listed applicant is Gen-Probe.

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 Gen-Probe 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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