FDA.report

DAPI solution IVD

Definition
A solution containing the fluorescent dye 4',6-Diamidino-2-phenylindole dihydrochloride (DAPI) intended to be used as a counterstain for the visualization of deoxyribonucleic acids (DNA) in assays performed on biological tissues or clinical specimens.
GUDID devices
11
Last updated
2023-04-26 16:24:32

Related Product Codes

CodeDeviceSpecialtyClassDevices
PPMGeneral Purpose ReagentPathology110
MVUReagents, Specific, AnalytePathology11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00810119673336EFISH DAPIBIOGENEX LABORATORIESHK606-10K2023-04-18
B502BSB01630FluoroMounter with DAPIBIO SB, INC.15 ml2020-09-30
B502BSB01640FluoroMounter with DAPIBIO SB, INC.50 ml2020-09-30
B502BSB01650FluoroMounter with DAPIBIO SB, INC.100 ml2020-09-30
B502BSB01660FluoroMounter with DAPIBIO SB, INC.200 ml2020-09-30
B502BSB01670FluoroMounter with DAPIBIO SB, INC.500 ml2020-09-30
B502BSB01680FluoroMounter with DAPIBIO SB, INC.1000 ml2020-09-30
00884999021624VysisABBOTT MOLECULAR INC.06J49-0012017-12-15
00884999021631VysisABBOTT MOLECULAR INC.06J49-0102017-12-15
00884999021648VysisABBOTT MOLECULAR INC.06J50-0012017-12-15
00884999026254VysisABBOTT MOLECULAR INC.07J06-0012017-12-15