FDA.reportPublic FDA data

Ki67 antigen 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 Ki67 antigen in a clinical specimen.
GUDID devices
110
Last updated
2026-06-16 06:05:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405007660Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0482026-06-05
00846405009473Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB0042026-06-05
00846405009480Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB004-052026-06-05
00846405009497Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB004-012026-06-05
00846405010233Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD0042026-06-05
00846405011766Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0262026-06-05
00846405011773Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP026-052026-06-05
00846405011780Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP026-012026-06-05
00846405017225Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD004-252026-06-05
00846405019069Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR048-HL2026-06-05
00846405019236Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD004-HL2026-06-05
00846405019939Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD004-10RM2026-06-05
00846405021994Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR048-S2026-06-05
00846405022007Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD004-S2026-06-05
00846405024834Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR048-10RP2026-06-05
00846405024841Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR048-252026-06-05
05055331334671BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0230-U2022-12-16
10190302012157Anti-Human Ki-67 FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMHKI67012018-06-15
07613336230947CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.102431980012025-07-07
00847627036797Ki-67 [MIB-1] BIOCARE MEDICAL LLCNPAI3156T402025-03-20
00847627036810Ki-67 [MIB-1] BIOCARE MEDICAL LLCNPAI3156T802025-03-20
00847627036995Ki-67BIOCARE MEDICAL LLCNPAI325T402025-03-20
00847627037008Ki-67BIOCARE MEDICAL LLCNPAI325T802025-03-20
B502BSB3767010Ki-67 (RM360)BIO SB, INC.BSB-3767-012025-03-18
B502BSB3767050Ki-67 (RM360)BIO SB, INC.BSB-3767-052025-03-18
B502BSB376710Ki-67 (RM360)BIO SB, INC.BSB-3767-12025-03-18
B502BSB3767150Tinto Ki-67 (RM360)BIO SB, INC.BSB-3767-152025-03-18
B502BSB376730Tinto Ki-67 (RM360)BIO SB, INC.BSB-3767-32025-03-18
B502BSB376770Tinto Ki-67 (RM360)BIO SB, INC.BSB-3767-72025-03-18
B502BSB3771150TintoFast Ki-67 (RM360)BIO SB, INC.BSB-3771-152025-03-18
B502BSB377130TintoFast Ki-67 (RM360)BIO SB, INC.BSB-3771-32025-03-18
B502BSB377170TintoFast Ki-67 (RM360)BIO SB, INC.BSB-3771-72025-03-18
00810170553387IHCSlmp, LLC(BTO) Sample Ki-67 (SP6) Antibody (2ml)2025-03-14
00810170551888IHCSlmp, LLCRTU Ki-67 (SP6) Antibody (10ml)2025-03-06
00810170551895IHCSlmp, LLC(BTO) RTU Ki-67 (SP6) Antibody (100ml)2025-03-06
00810170551901IHCSlmp, LLC(BTO) RTU Ki-67 (SP6) Antibody (25ml)2025-03-06
B502BSB57080Tinto Ki-67, RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB57100Tinto Ki-67, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB57110Ki-67 RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB57120Ki-67 RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB57130Ki-67 RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00847627024121KI-67 [MIB-1]BIOCARE MEDICAL LLCALI3156G25 2024-06-27
06931988329293Rabbit Monoclonal Anti-Human Ki67(MXR002) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-0731 10mL2024-02-01
06931988330732Rabbit Monoclonal Anti-Human Ki67(MXR002) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-0731 90mL2024-02-01
06931988329286Mouse Monoclonal Anti-Human Ki-67(MX006) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0672 10mL2024-01-31
06931988330060Mouse Monoclonal Anti-Human Ki-67(MX006) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0672 90mL2024-01-31
06931988315265Rabbit Monoclonal Anti-Human Ki67(MXR002) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-0731 1.0mL2024-01-26
06931988302593Mouse Monoclonal Anti-Human Ki-67(MX006) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0672 1.0mL2024-01-25
06931988302586Mouse Monoclonal Anti-Human Ki-67(MX006) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0672 0.2mL2024-01-23
06931988315258Rabbit Monoclonal Anti-Human Ki67(MXR002) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-0731 0.2mL2024-01-24
05055331333902NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDKI67-MM1-L-U2023-07-28
05055331334428BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0118-U2023-07-28
05055331335029BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0410-U2023-07-28
00810113060279Rabbit Monoclonal Anti-Human Ki-67 Antibody, EP5Epitomics Inc.AC-00092023-06-07
00810113060286Rabbit Monoclonal Anti-Human Ki-67 Antibody, EP5Epitomics Inc.AC-0009A2023-06-07
00810113060293Rabbit Monoclonal Anti-Human Ki-67 Antibody, EP5Epitomics Inc.AC-0009B2023-06-07
00810113060309Rabbit Monoclonal Anti-Human Ki-67 Antibody, EP5Epitomics Inc.AC-0009BULK2023-06-07
00810119676177ANTI-KI-67BIOGENEX LABORATORIESMU370-UC2023-05-08
00810119676870ANTI-KI-67 AGBIOGENEX LABORATORIESAM297-10M2023-05-04
00810119676962ANTI-KI 67BIOGENEX LABORATORIESAN727-10M2023-05-04
00810119677907ANTI-KI67BIOGENEX LABORATORIESAM410-10M2023-04-24
00810119678065ANTI-KI-67BIOGENEX LABORATORIESAM370-10M2023-04-24
00810119678898ANTI-KI67BIOGENEX LABORATORIESMU410-UC2023-04-24
00810119677785KI-67 AGBIOGENEX LABORATORIESFG-297M2023-04-21
00810119676559ANTI-KI-67 AntigenBIOGENEX LABORATORIESAX297-YCD2023-04-20
00810119674159ANTI-KI67BIOGENEX LABORATORIESMU410-5UC2023-04-19
00810119674821ANTI-KI-67 AGBIOGENEX LABORATORIESMU297-UC2023-04-19
00810119673824ANTI-KI-67 AGBIOGENEX LABORATORIESMU297-5UC2023-04-18
00810119671974ANTI-KI67BIOGENEX LABORATORIESAMA01-5M2023-04-05
00810119671417ANTI-KI 67BIOGENEX LABORATORIESAN727-5M2023-04-03
00810119670984ANTI-KI67BIOGENEX LABORATORIESAM410-5M2023-03-31
00810119670991ANTI-KI-67BIOGENEX LABORATORIESAM370-5M2023-03-31
00810119670052ANTI-KI-67 AGBIOGENEX LABORATORIESAM297-5M2023-03-28
00615233010674Tissue-Tek Genie® SAKURA FINETEK U.S.A., INC.8276-C0102023-02-28
00615233010681Tissue-Tek Genie® SAKURA FINETEK U.S.A., INC.8276-M2502023-02-28
00841683107224Ki-67 (SP6) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION275R-102022-11-14
00841683132295Ki-67 (SP6) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION275R-142022-11-14
00841683132301Ki-67 (SP6) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION275R-152022-11-14
00841683132325Ki-67 (SP6) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION275R-172022-11-14
00382906651273N/ABecton, Dickinson And Company6651272022-10-12