FDA 510(k)

Lyra RSV+hMPV Assay

Número K: K230349 · 2023-03-10

Data da decisão2023-03-10

Código do produtoOEM

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lyra RSV+hMPV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K230349. The device is classified under product code OEM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lyra RSV+hMPV Assay?

Lyra RSV+hMPV Assay is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Quidel Corporation. The 510(k) number is K230349.

When did Lyra RSV+hMPV Assay receive FDA 510(k) clearance?

Lyra RSV+hMPV Assay received FDA 510(k) clearance on 2023-03-10, under 510(k) number K230349.

Who is the listed applicant for Lyra RSV+hMPV Assay?

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

What is the FDA product code for Lyra RSV+hMPV Assay?

The FDA product code for Lyra RSV+hMPV Assay is OEM.

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Outros registros que listam Quidel Corporation como candidato(a)

K231795QuickVue COVID-19 Test K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument K233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set K230236Lyra Influenza A+B Assay K211342Sofia 2 Campylobacter FIA K173496Sofia 2 Lyme FIA, Sofia Lyme Control Set

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Fonte oficial

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