FDA 510(k)

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)

N.º K: K252387 · 2025-10-30

Fecha de decisión2025-10-30

Código de productoQOF

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252387. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)?

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K252387.

When did Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) receive FDA 510(k) clearance?

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252387.

Who is the listed applicant for Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)?

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

What is the FDA product code for Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)?

The FDA product code for Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) is QOF.

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Otros registros que enlistan a Diasorin Molecular, LLC como solicitante

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit K251978LIAISON NES FLU A/B, RSV & COVID-19 K220963Simplexa COVID-19 & Flu A/B Direct K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack K212147Simplexa COVID-19 Direct K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

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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.