Device Directory
Browse 178 FDA-cleared medical devices
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243274)
Class Class II K243274 OZE
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084)
Class Class II K250084 LTT
Alinity m EBV (09N43-095) (K243489)
Class Class II K243489 QLX
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455)
Class Class II K243455 QOF
MycoMEIA Aspergillus Assay (K243496)
Class Class I K243496 NOM
BD Phoenix Automated Microbiology System – GN Eravacycline (0.125-2 µg/mL) (K251713)
Class Class II K251713 LON
Sulopenem SPM 2 µg (K251879)
Class Class II K251879 JTN
MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495)
Class Class II K251495 QBN
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (K243544)
Class Class II K243544 QOF
FilmArray GI Control Panel M238 (K251526)
Class Class II K251526 PMN
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