FDA.reportPublic FDA data

CD34 cell marker IVD, antibody

Definition
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD34 cell marker in a clinical specimen.
GUDID devices
89
Last updated
2026-09-04 23:12:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05700572515890Mono Mo A-Hu CD34 Class III/FITC Cl BIRMA-K3AGILENT TECHNOLOGIES SINGAPORE PTE LTDF70812020-09-17
05700572516361Mono Mo a Hu CD34 Class III/RPE, Cl BIRMA-K3AGILENT TECHNOLOGIES SINGAPORE PTE LTDR71252020-09-17
00846405005055Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob0982026-06-05
00846405005062Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob098-052026-06-05
00846405005079Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob098-012026-06-05
00846405007226Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0502026-06-05
00846405008971Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB058-012026-06-05
00846405008988Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB058-052026-06-05
00846405008995Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB0582026-06-05
00846405010042Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD0582026-06-05
00846405010646Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD058-S2026-06-05
00846405018086Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM050-HL2026-06-05
00846405019687Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM050-10MM2026-06-05
00846405021185Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM050-S2026-06-05
00847627038463CD34BIOCARE MEDICAL LLCNPAI084T402025-03-20
00847627038470CD34BIOCARE MEDICAL LLCNPAI084T802025-03-20
00810170552809IHCSlmp, LLC(BTO) Sample CD34, Endothelial CellAntibody (2ml)2025-03-12
00810170550942IHCSlmp, LLC(BTO) RTU CD34, Endothelial Cell (QBEND/10) Antibo2025-03-05
B502BSB52250Tinto CD34, MMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB52260Tinto CD34, MMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB52280CD34 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB52290CD34 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB52300CD34 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB64870Tinto CD34, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB64880CD34 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB64890CD34 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB64900CD34 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
00382906666628HorizonBecton, Dickinson And Company6666622025-02-04
06931988328906Mouse Monoclonal Anti-Human CD34(MX123) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1076 10mL2024-02-01
06931988331081Mouse Monoclonal Anti-Human CD34(MX123) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1076 90mL2024-02-01
06931988326308Mouse Monoclonal Anti-Human CD34(MX123) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1076 1.0mL2024-01-26
06931988326131Mouse Monoclonal Anti-Human CD34(MX123) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1076 0.2mL2024-01-24
05055331333711NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDEND-L-U2023-07-28
05055331334633BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0212-U2023-07-28
05055331334893BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0354-U2023-07-28
00810119674937ANTI-CD34BIOGENEX LABORATORIESMU236-UC2023-05-04
00810119675071ANTI-CD34BIOGENEX LABORATORIESNU779-UC2023-05-04
00810119679123CD34BIOGENEX LABORATORIESMU236-UC2023-04-25
00810119677280ANTI-CD34BIOGENEX LABORATORIESAM236-10M2023-04-20
00810119674708ANTI-CD34BIOGENEX LABORATORIESMU236-5UC2023-04-19
00810119670144ANTI-CD34BIOGENEX LABORATORIESAM236-5M2023-03-28
00850036867449Q-STAIN® QSX-Enh-F CD34NOVODIAX, INC.QF31046-0042023-03-20
00850036867555Q-STAIN® QSX-Enh-P CD34NOVODIAX, INC.QP31046-0042023-03-20
00850041202389ihc CD34 Ab (3mL)NOVODIAX, INC.KF31046-0032023-03-20
00850041202396ihc CD34 Ab (5mL)NOVODIAX, INC.KF31046-0052023-03-20
00841683105527CD34 (EP88) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION134R-182022-11-14
00841683105534CD34 (EP88) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION134R-172022-11-14
00841683105541CD34 (EP88) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION134R-152022-11-14
00841683105558CD34 (EP88) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION134R-162022-11-14
00841683105565CD34 (EP88) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION134R-142022-11-14
00841683124610CD34 (QBEnd/10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION134M-142022-11-14
00841683124627CD34 (QBEnd/10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION134M-152022-11-14
00841683124641CD34 (QBEnd/10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION134M-172022-11-14
00841683124658CD34 (QBEnd/10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION134M-182022-11-14
00382906639813HorizonBecton, Dickinson And Company6639812020-11-11
05055331304476BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA02122021-03-26
05055331309785Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDEND-L-CE2021-03-26
05055331322517BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA03542021-03-26
04015630971817CONFIRM anti-CD34 [QBEnd/10] Primary AntibodyVentana Medical Systems, Inc.052782100012021-01-29
00841683100089CD34 (QBEnd/10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-26202020-12-14
00841683124634CD34 (QBEnd/10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION134M-162020-12-07
05700572006688Mono Mo A-Hu CD34 Class II Cl QBEnd 10AGILENT TECHNOLOGIES SINGAPORE PTE LTDM71652020-09-17
05700572007081Mono Mo A-Hu CD34 Class III/APC Cl BIRMA-K3AGILENT TECHNOLOGIES SINGAPORE PTE LTDC72382020-09-17
05700572027874Mono Mo A-Hu CD34 Class II Cl QBEnd 10AGILENT TECHNOLOGIES SINGAPORE PTE LTDM71652020-09-17
05700572029410FLEX Mono Mo A-Hu CD34 Class II Cl QBEnd 10 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6322020-09-17
05700572029717FLEX Mono Mo A-Hu CD34 Class II Cl QBEnd 10 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6322020-09-17
05700572033073FLEX Mono Mo A-Hu CD34 Class II Cl QBEnd 10 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6322020-09-17
08809317540634ADAMII-CD34 KitNanoEnTek, Inc.CD34K-0502020-09-02
B502BSB36810TintoFast CD34 MMabBIO SB, INC.Predilute, 3ml2020-08-31
B502BSB36820TintoFast CD34 MMabBIO SB, INC.Predilute, 7ml2020-08-31
B502BSB36830TintoFast CD34 MMabBIO SB, INC.Predilute, 15ml2020-08-31
B502BSB52270Tinto CD34 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
B502BSB64850Tinto CD34 RMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB64860Tinto CD34 RMabBIO SB, INC.Predilute, 7 ml 2020-08-31
L502BSB5228CD34 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB5229CD34 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB5230CD34 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
L502BSB6488CD34 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB6489CD34 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB6490CD34 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16