FDA.reportPublic FDA data

Biological stain IVD

Definition
A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.
GUDID devices
631
Last updated
2026-07-15 00:47:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03760177194519Ral Diff-Quik EZ-Kit (3 x 100ml)R.A.L. DIAGNOSTICS037601771945192018-09-07
03760177194526Ral Diff-Quik Kit (3 x 500ml)R.A.L. DIAGNOSTICS037601771945262018-09-07
03760177194533Ral Diff-Quik Fixative Solution (1 x 2,5L)R.A.L. DIAGNOSTICS037601771945332018-09-07
03760177194540Ral Diff-Quik Solution I (1 x 2,5L)R.A.L. DIAGNOSTICS037601771945402018-09-07
03760177194557Ral Diff-Quik Solution II (1 x 2,5L)R.A.L. DIAGNOSTICS037601771945572018-09-07
00846405013265Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0272026-06-09
00846405013340Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0252026-06-09
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0982026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.K098-S2026-06-09
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.K056-100AN2026-06-08
00846405013210Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0332026-06-08
00846405013234Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0042026-06-08
00846405013319Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0072026-06-08
00846405013371Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0232026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0952026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.K1002026-06-08
00846405023356Diagnostic BioSystemsDiagnostic Biosystems, Inc.K056-S2026-06-08
00846405023394Diagnostic BioSystemsDiagnostic Biosystems, Inc.K095-S2026-06-08
00846405023660Diagnostic BioSystemsDiagnostic Biosystems, Inc.K100-S2026-06-08
00846405013111Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0142026-06-05
00846405013128Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0132026-06-05
00846405013142Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0352026-06-06
00846405013159Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0362026-06-07
00846405013173Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0282026-06-07
00846405013203Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0372026-06-05
00846405013326Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0292026-06-05
00846405013333Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0222026-06-05
00613647023112FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1002022-12-07
00613647023129FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1012022-12-07
00613647023136FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1022022-12-07
00613647023143FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1032022-12-07
00613647023150FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1042022-12-07
00613647023167FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1052022-12-07
00613647023174FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1062022-12-07
00613647023204FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.220-1092022-12-07
00613647023631FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CS-4322022-12-07
00613647023648FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CS-4342022-12-07
00630414619248Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.115598622026-02-06
00630414619255Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.115598632026-02-06
00630414619262Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.115598652026-02-06
00630414626253Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.115598642026-02-06
00673693068161EprediaRICHARD-ALLAN SCIENTIFIC COMPANYBuffered Wright Stain 2024-09-05
00673693068192EprediaRICHARD-ALLAN SCIENTIFIC COMPANYBuffered Wright - Giemsa Stain2024-09-05
00673693089166EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIron Stain Kit2024-09-05
00673693089210EprediaRICHARD-ALLAN SCIENTIFIC COMPANYMethyl Green-Pyronin Y Stain Solution2024-09-05
00673693089258EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGram Stain Kit - Film2024-09-05
00673693089487EprediaRICHARD-ALLAN SCIENTIFIC COMPANYTartrazine Stain Solution2024-09-05
00673693089500EprediaRICHARD-ALLAN SCIENTIFIC COMPANYPotassium Ferrocyanide Solution2024-09-05
00673693089524EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHydrochloric Acid Solution (20%)2024-09-05
00673693089548EprediaRICHARD-ALLAN SCIENTIFIC COMPANYNuclear Red Thiazin Solution2024-09-05
00673693089623EprediaRICHARD-ALLAN SCIENTIFIC COMPANYBiebrich Scarlet- Acid Fuchsin Solution2024-09-05
00673693089647EprediaRICHARD-ALLAN SCIENTIFIC COMPANYPhosphotungstic - Phosphomolybdic Acid Solution2024-09-05
00673693089685EprediaRICHARD-ALLAN SCIENTIFIC COMPANYAniline Blue Stain Solution2024-09-05
00673693089869EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGomori’s Trichrome Stain Green Collagen2024-09-05
00673693090001EprediaRICHARD-ALLAN SCIENTIFIC COMPANYCrystal Violet Solution2024-09-05
00673693090025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGram's Iodine Solution2024-09-05
00673693090049EprediaRICHARD-ALLAN SCIENTIFIC COMPANYSafranin O Stain Solution2024-09-05
00673693090063EprediaRICHARD-ALLAN SCIENTIFIC COMPANYDecolorizing Solution2024-09-05
00673693090179EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLugol's Iodine Solution2024-09-05
00673693090209EprediaRICHARD-ALLAN SCIENTIFIC COMPANYSodium Bicarbonate Solution2024-09-05
00673693090353EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGiemsa Stain2024-09-05
00673693090377EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGiemsa Stain2024-09-05
00673693090384EprediaRICHARD-ALLAN SCIENTIFIC COMPANYWright Stain2024-09-05
00673693090407EprediaRICHARD-ALLAN SCIENTIFIC COMPANYWright Stain2024-09-05
00673693090414EprediaRICHARD-ALLAN SCIENTIFIC COMPANYWright - Giemsa Stain2024-09-05
00673693090421EprediaRICHARD-ALLAN SCIENTIFIC COMPANYWright - Giemsa Stain2024-09-05
00673693090438EprediaRICHARD-ALLAN SCIENTIFIC COMPANYWright - Giemsa Stain2024-09-05
00673693090445EprediaRICHARD-ALLAN SCIENTIFIC COMPANYMay-Grunwald Stain2024-09-05
00673693090469EprediaRICHARD-ALLAN SCIENTIFIC COMPANYReticulocyte Stain2024-09-05
00673693090476EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJenner Stain2024-09-05
00673693169011EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGram Stain Kit -Tissue2024-09-05
00673693169028EprediaRICHARD-ALLAN SCIENTIFIC COMPANYMasson Trichrome Stain Kit2024-09-05
00673693169042EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGomori’s Trichrome Stain Kit Green Collagen2024-09-05
00673693236409EprediaRICHARD-ALLAN SCIENTIFIC COMPANYWright Giemsa Stain Kit2024-09-05
00673693236461EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGram Stain Kit2024-09-05
00673693236478EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGram Crystal Violet Stain2024-09-05
00805360018395Spermac Stain VITROLIFE INC.155122018-04-23
00805360018401Spermac Stain VITROLIFE INC.155132018-04-23
00810047420149N/AScientific Device Laboratory, Inc.3732023-01-30
00810047420156N/AScientific Device Laboratory, Inc.3792023-01-30