Device Directory
Browse 30 FDA-cleared medical devices
AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (K243996)
Class Class II K243996 NFT
Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067)
Class Class II K250067 NGL
Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (K250803)
Class Class II K250803 NGL
LZI Fentanyl III Enzyme Immunoassay (K251634)
Class Class II K251634 DJG
ARCHITECT iGentamicin (K243500)
Class Class II K243500 LCD
Diazyme Colorimetric Lithium Assay (K243462)
Class Class II K243462 NDW
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259)
Class Class II K252259 NFT
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit – Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972)
Class Class II K251972 DJG
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118)
Class Class II K252118 NFT
SEFRIA™ Hydrocodone Oral Fluid (K252520)
Class Class II K252520 DJG
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