510(k) Report

Devices descending from DEN220039

12 later devices reach Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254264Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)20260—
+1K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC20240—
+1K231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation20244—
+1K233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation20230—
+1K221925ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc.202332
+2K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+2K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.20260—
+2K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.20250—
+2K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and Company20250—
+2K250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.20250—
+2K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20231—
+3K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc.20250—