510(k) Report

Devices descending from K131813

7 later devices reach Quidel Molecular RSV + HMPV Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230349Lyra RSV+hMPV AssayQuidel Corporation20230—
+1K171974Solana RSV+hMPV AssayQuidel Corporation20170—
+1K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc.201642
+2K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+3K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+3K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+4K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—