510(k) Report

Devices descending from DEN070013

106 later devices reach ID-Tag Respiratory Viral Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.20167—
+7K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20260—
+7K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20230—
+7K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.201761
+8K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+9K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312