FDA 510(k)

BD Veritor System for SARS-CoV-2

Número K: K243872 · 2025-06-16

Data da decisão2025-06-16

Código do produtoQVF

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Veritor System for SARS-CoV-2 is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K243872. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Veritor System for SARS-CoV-2?

BD Veritor System for SARS-CoV-2 is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K243872.

When did BD Veritor System for SARS-CoV-2 receive FDA 510(k) clearance?

BD Veritor System for SARS-CoV-2 received FDA 510(k) clearance on 2025-06-16, under 510(k) number K243872.

Who is the listed applicant for BD Veritor System for SARS-CoV-2?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Veritor System for SARS-CoV-2?

The FDA product code for BD Veritor System for SARS-CoV-2 is QVF.

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Fonte oficial

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