Device Directory
Browse 178 FDA-cleared medical devices
Elecsys Anti-HCV II (08837031190) (K221693)
Class Class II K221693 MZO
Selux AST System; Model AST Gen 1.0 (K211759)
Class Class II K211759 LON
Biosci Inactivated Transport Medium, Biosci ITM (K220059)
Class Class II K220059 QBD
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)
Class Class II K221899 NGZ
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)
Class Class II K223016 PSZ
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 – =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 – =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803)
Class Class II K220803 LON
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481)
Class Class II K223481 LON
Active Anthrax DetectTM Plus Rapid Test (DEN220044)
Class Class II DEN220044 QUU
BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954)
Class Class II K213954 QOF
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253)
Class Class II K221253 PMN
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