Device Directory
Browse 178 FDA-cleared medical devices
Xpert® SA Nasal Complete (K243070)
Class Class II K243070 NQX
QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256)
Class Class II K242256 PLO
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367)
Class Class II K242367 PCH
DASH® SARS-CoV-2 & Flu A/B Test (K241652)
Class Class II K241652 QOF
QIAstat-Dx GI Panel 2 Mini B&V (K243813)
Class Class II K243813 PCH
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (K241806)
Class Class II K241806 QOF
Xpert Xpress CoV-2/Flu/RSV plus (K242071)
Class Class II K242071 QOF
BioCode Gastrointestinal Pathogen Panel (GPP) (K242877)
Class Class II K242877 PCH
TriVerity (K241676)
Class Class II K241676 PRE
QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (K243262)
Class Class II K243262 SCA
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