FDA.reportPublic FDA data

Blood cell lysis reagent IVD

Definition
A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.
GUDID devices
83
Last updated
2026-06-18 06:05:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00380740136963AlinityABBOTT LABORATORIES07P81042023-11-16
00380740020149CELL-DYNABBOTT LABORATORIES09H47-022016-06-06
00380740120771CELL-DYNABBOTT LABORATORIES09H61012016-09-09
00664369000899LYSERCELL WDF IISYSMEX CORPORATIONCY7540192026-04-24
03610230004425ABX BASOLYSEHORIBA ABX SAS12102040502016-05-02
03610230004432ABX EOSINOFIX (1L)HORIBA ABX SAS12102060102016-08-23
03610230004456ABX LEUCODIFF 1LHORIBA ABX SAS12102060132016-08-23
03610230004548ABX MINILYSE (1L)HORIBA ABX SAS12107010102016-09-02
03610230004555ABX MINILYSE LMG (1L)HORIBA ABX SAS12107020102016-08-16
03610230004654ABX BASOLYSE IIHORIBA ABX SAS12109060032016-08-16
03610230004661ABX ALPHALYSE (0.4L)HORIBA ABX SAS12109060042016-08-16
03610230004685ABX LYSEBIO (1L)HORIBA ABX SAS12109060122016-09-17
03610230004692ABX LYSEBIO (0.4L)HORIBA ABX SAS12109060132016-08-16
03610230004708ABX ALPHALYSE (360mL)HORIBA ABX SAS12109060142016-08-16
03610230004715MINILYSEBIO (1L)HORIBA ABX SAS12109060192017-01-09
03610230004722MINILYSEBIO (0.4L)HORIBA ABX SAS12109060202016-09-02
03610230004746WHITEDIFF (1L)HORIBA ABX SAS12109060222016-08-16
04987562422982Lysercell WNRSYSMEX CORPORATIONAN5770632022-11-30
04987562422999LYSERCELL WDFSYSMEX CORPORATIONAW9936052022-11-30
04987562423002Lysercell WPCSYSMEX CORPORATIONCS4128002022-11-30
04987562432325LYSERCELL WDF SYSMEX CORPORATIONBG6896802022-11-30
05700571112748EasyLyse Erythrocyte-Lysing ReagentAGILENT TECHNOLOGIES SINGAPORE PTE LTDS23642020-09-17
05999883586167Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagD3022023-04-24
10664369000650XW pack LSYSMEX CORPORATIONZA9000062022-11-04
10664369200548STROMATOLYSER-WHSYSMEX CORPORATIONSWH-200A2022-11-04
10664369402560pocH-pack LSYSMEX CORPORATIONPPL-200A2022-11-04
06903053010641M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-30CFL2026-01-22
06936415908805M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-30CFL2026-01-22
06936415908812M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-30CFL2026-01-22
06944904093116M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-5LEO(I)2026-01-22
06944904093123M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-5LEO(I)2026-01-22
06944904093130M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-5LEO(II)2026-01-22
06944904093147M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-5LEO(II)2026-01-22
06944904093154M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-53LH2026-01-22
06944904093161M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.M-53LH2026-01-22
EBUHBCCRLYR20CAST® Lysing Reagent BasophilBühlmann Laboratories AGB-CCR-LYR202025-03-04
03610230005460ABX PENTRA HBA1C WB HEMOLYSIS REAGENTHORIBA ABX SAS12200017302016-09-17
03610230008157NUCEDIFF (1L)HORIBA ABX SAS13000270302024-05-30
07540207107490EasySep™ Red Blood Cell Lysis Buffer, 10X ConcentrateStemcell Technologies Canada Inc100-07492024-02-08
G507ZAPR01000ZAPR™Incell Corporation, LLCZAPR01002023-09-06
G507ZAPR04000ZAPR™Incell Corporation, LLCZAPR04002023-09-06
10811877010965ISOLATOR™ 10 mL Microbial TubesAlere Scarborough, Inc.50C72016-09-05
05999883586105Diatro•Lyse-DIFFDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagD2012023-04-24
15999883586164Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagD3022023-04-24
04987562022090STROMATOLYSER-3WPSYSMEX CORPORATION854001212022-11-30
04987562022335STROMATOLYSER-FBSYSMEX CORPORATION944045162022-11-30
04987562200269STROMATOLYSER-IMSYSMEX CORPORATION934032132022-11-30
04987562201389STROMATOLYSER-4DS SYSMEX CORPORATION984172162022-11-30
04987562201402STROMATOLYSER-4DLSYSMEX CORPORATION984176152022-11-30
04987562407767STROMATOLYSER-4DL SYSMEX CORPORATION054332122022-11-30
04987562499809LYSERCELL WDFSYSMEX CORPORATION AZ1248012022-11-30
14987562422996LYSERCELL WDFSYSMEX CORPORATIONAW9936052022-11-30
14987562432322LYSERCELL WDF SYSMEX CORPORATIONBG6896802022-11-30
84987562422988Lysercell WNRSYSMEX CORPORATIONAN5770632022-11-30
84987562423008Lysercell WPCSYSMEX CORPORATIONCS4128002022-11-30
05999883586150Diatro•Lyse-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagD3012022-11-22
00664369000042STROMATOLYSER-NR (L)SYSMEX CORPORATIONSNR-210A2022-11-04
00664369000509LYSERCELL WDFSYSMEX CORPORATIONZA9000012022-11-04
00664369000516LYSERCELL WNRSYSMEX CORPORATIONZA9000022022-11-04
00664369200220STROMATOLYSER-FBSYSMEX CORPORATIONFBA-200A2022-11-04
00664369200268STROMATOLYSER-IMSYSMEX CORPORATIONSIM-220A2022-11-04
00664369201395Stromatolyser-NRSYSMEX CORPORATIONSNR-700A2022-11-04
00664369201418STROMATOLYSER-4DLSYSMEX CORPORATIONFFD-200A2022-11-04
80664369000659XW pack LSYSMEX CORPORATIONZA9000062022-11-04
80664369200547STROMATOLYSER-WHSYSMEX CORPORATIONSWH-200A2022-11-04
80664369402569pocH-pack LSYSMEX CORPORATIONPPL-200A2022-11-04
10190302008884Cal-Lyse™ Lysing Solution 1000 TestsLIFE TECHNOLOGIES CORPORATIONGAS010S1002018-02-02
10190302014038High-Yield Lyse Fixative-Free Lysing SolutionLIFE TECHNOLOGIES CORPORATIONHYL2502018-02-02
10811877010958ISOLATOR™ 1.5 mL Microbial TubesAlere Scarborough, Inc.50C52020-10-23
05700572013693EasyLyse Erythrocyte-Lysing ReagentDako Denmark ApSS23642020-09-17
00859882007757Procleix Parasite Transport MediumGRIFOLS DIAGNOSTIC SOLUTIONS INC.Lysis Buffer2019-03-20
00630414601281ADVIA® 360 Lyse 3P DiffSiemens Healthcare Diagnostics Inc.111708482016-09-24
00630414601878ADVIA® 560 LyseSiemens Healthcare Diagnostics Inc.111708462016-09-24
00380740001155CELL-DYNABBOTT LABORATORIES01H79-012016-09-09
00380740005115CELL-DYNABBOTT LABORATORIES03H62-012016-06-06
00380740005146CELL-DYNABBOTT LABORATORIES03H78-012016-09-09
00380740005160CELL-DYNABBOTT LABORATORIES03H80-022016-06-06
00380740013547CELL-DYNABBOTT LABORATORIES07H84-012016-09-09
00380740017026CELL-DYNABBOTT LABORATORIES08H52-012016-06-06
00380740020965CELL-DYNABBOTT LABORATORIES99311-012016-06-06