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PMA de la FDA

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

Número de PMA: P180047 · 2026-09-24

SolicitanteDiaSorin, Inc.
Fecha de decisión2026-09-24
Número PMAP180047
Código de productoNCD
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorMI

Resumen del dispositivo

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2026-09-24. The device is classified under product code NCD. It was reviewed by the MI advisory panel.

Preguntas frecuentes

What is the TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is DiaSorin, Inc..

When did TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS receive FDA 510(k) clearance?

The clearance date for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS can be found in the official FDA records.

Who is the listed applicant for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

The FDA product code for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is NCD.

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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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