510(k) Report

Devices descending from K213362

2 later devices reach BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253653Xpert Hemorrhagic FeverCepheid20261—
+2K261362Xpert Hemorrhagic FeverCepheid20260—