FDA 510(k)

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

N.º K: K233688 · 2023-12-13

Fecha de decisión2023-12-13

Código de productoQVF

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K233688. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Quidel Corporation. The 510(k) number is K233688.

When did Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set receive FDA 510(k) clearance?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set received FDA 510(k) clearance on 2023-12-13, under 510(k) number K233688.

Who is the listed applicant for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

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 Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

The FDA product code for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is QVF.

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Otros registros que enlistan a Quidel Corporation como solicitante

K231795QuickVue COVID-19 Test K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument K230349Lyra RSV+hMPV Assay K230236Lyra Influenza A+B Assay K211342Sofia 2 Campylobacter FIA K173496Sofia 2 Lyme FIA, Sofia Lyme Control Set

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Dispositivos relacionados (Código: QVF)

K254264Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and Company K250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.

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.