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PMA de la FDA

ASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGG

Número de PMA: P220034 · 2026-08-18

SolicitanteDiaSorin, Inc.
Fecha de decisión2026-08-18
Número PMAP220034
Código de productoMYL
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorMI

Resumen del dispositivo

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2026-08-18. The device is classified under product code MYL. It was reviewed by the MI advisory panel.

Preguntas frecuentes

What is the ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is DiaSorin, Inc..

When did ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG receive FDA 510(k) clearance?

The clearance date for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG can be found in the official FDA records.

Who is the listed applicant for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

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 ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is MYL.

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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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