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Multi-Analyte Respiratory Virus Antigen Detection Test
FDA product code SCA · Class 2 · Microbiology
65
Registered devices
49
Adverse events
0
Recalls
12
510(k) clearances
Devices with this code
McKesson — MCKESSON MEDICAL-SURGICAL INC.BinaxNOW COVID-19/Flu A&B — Alere Scarborough, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.QuickVue™ — WONDFO USA CO., LTD.BinaxNOW COVID-19/Flu A&B Combo Self Test — Alere Scarborough, Inc.Rapid Response — BTNX IncCareSuperb COVID-19/FluA&B Antigen Combo HomeTest — Access Bio Inc.GenaCheck® COVID-19/Flu A&B Rapid Self-Test — Genabio Diagnostics Inc.Flowflex Plus COVID-19 + Flu A/B Home Test — Acon Laboratories, Inc.HealthConfirm — CONFIRM BIOSCIENCES, INC.WELLlife™ — WONDFO USA CO., LTD.QuickFinder™ COVID-19/Flu Antigen Self Test — OSANG HEALTHCARE Co., Ltd.WELLlife™ — WONDFO USA CO., LTD.BinaxNOW COVID-19/Flu A&B Combo Self Test — Alere Scarborough, Inc.QuickFinder™ COVID-19/Flu Antigen ProTest — OSANG HEALTHCARE Co., Ltd.Nano-Check Influenza+COVID-19 Dual Test — NANO-DITECH CORPORATIONiHealth — IHEALTH LAB INC.statID Pro COVID-19/Flu A&B — MERIDIAN BIOSCIENCE, INC.CareSuperb COVID-19/FluA&B Antigen Combo HomeTest — Access Bio Inc.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHealgen — Healgen Scientific Limited Liability CompanyHealthConfirm — CONFIRM BIOSCIENCES, INC.iHealth — IHEALTH LAB INC.statID Pro COVID-19/Flu External Controls — MERIDIAN BIOSCIENCE, INC.
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