Device Directory
Browse 178 FDA-cleared medical devices
Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109)
Class Class II K242109 QQX
WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (K243256)
Class Class II K243256 SCA
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885)
Class Class II K243885 PCH
cobas® liat CT/NG/MG nucleic acid test (K240197)
Class Class II K240197 QEP
Aptima CMV Quant Assay (K243935)
Class Class II K243935 PAB
cobas® liat CT/NG nucleic acid test (K240217)
Class Class II K240217 QEP
CareSuperb™ COVID-19 Antigen Home Test (K241915)
Class Class II K241915 QYT
MTS Ceftobiprole 0.002-32 µg/mL (K243202)
Class Class II K243202 JWY
simpli-COLLECT STI Test (K243410)
Class Class II K243410 QYA
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL (K243201)
Class Class II K243201 JWY
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