Device Directory
Browse 178 FDA-cleared medical devices
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL (K242905)
Class Class II K242905 JWY
BinaxNOW™ COVID-19 Antigen Self Test (K243518)
Class Class II K243518 QYT
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867)
Class Class II K240867 QQX
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575)
Class Class II K243575 MYF
Aptima SARS-CoV-2 Assay (K243396)
Class Class II K243396 QQX
Alinity m Resp-4-Plex (K241573)
Class Class II K241573 QOF
Visby Medical Respiratory Health Test (K242526)
Class Class II K242526 QOF
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (K242658)
Class Class II K242658 JWY
Acucy® Influenza A&B Test with the Acucy® 2 System (K241188)
Class Class II K241188 PSZ
LIAISON PLEX Gram-Negative Blood Culture Assay (K243013)
Class Class II K243013 PEN
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