Device Directory
Browse 178 FDA-cleared medical devices
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073)
Class Class II K222073 LON
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478)
Class Class II K223478 LON
Spectrum Saliva Collection Device (K223497)
Class Class II K223497 QBD
Alinity m STI Assay (K222379)
Class Class II K222379 QEP
Lyra Influenza A+B Assay (K230236)
Class Class II K230236 OZE
BD Vaginal Panel (K223653)
Class Class II K223653 PQA
Visby Medical Sexual Health Test (K220407)
Class Class II K220407 QEP
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039)
Class Class II DEN220039 QVF
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430)
Class Class II K222430 LON
Lyra RSV+hMPV Assay (K230349)
Class Class II K230349 OEM
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