FDA 510(k)

BinaxNOW COVID-19 Ag Card

Número K: K250273 · 2025-06-13

RequerenteAbbott Diagnostics Scarborough, Inc.

Data da decisão2025-06-13

Código do produtoQVF

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BinaxNOW COVID-19 Ag Card is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250273. 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 BinaxNOW COVID-19 Ag Card?

BinaxNOW COVID-19 Ag Card is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K250273.

When did BinaxNOW COVID-19 Ag Card receive FDA 510(k) clearance?

BinaxNOW COVID-19 Ag Card received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250273.

Who is the listed applicant for BinaxNOW COVID-19 Ag Card?

The FDA 510(k) record lists Abbott Diagnostics Scarborough, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BinaxNOW COVID-19 Ag Card?

The FDA product code for BinaxNOW COVID-19 Ag Card is QVF.

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Outros registros que listam Abbott Diagnostics Scarborough, Inc. como candidato(a)

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 K243518BinaxNOW™ COVID-19 Antigen Self Test K232775ID NOW Influenza A & B 2 K221925ID NOW COVID-19 2.0 K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 K191534ID NOW Influenza A & B 2

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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 K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC

Fonte oficial

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