Device Directory
Browse 178 FDA-cleared medical devices
COVID-19 Detect Rapid Self -Test (K251595)
Class Class II K251595 QYT
WELLlife COVID-19 Antigen Test Rx (K251289)
Class Class II K251289 QVF
Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749)
Class Class II K251749 SCA
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329)
Class Class II K252329 PCH
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K251875)
Class Class II K251875 SAN
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (K252387)
Class Class II K252387 QOF
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System (K250358)
Class Class II K250358 PCI
cobas CMV (K252481)
Class Class II K252481 PAB
cobas HCV (K252484)
Class Class II K252484 MZP
Status™ COVID-19/Flu A&B (K251538)
Class Class II K251538 SCA
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