FDA.reportPublic FDA data

CD117 (c-kit) 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 CD117 (c-kit) cell marker in a clinical specimen.
GUDID devices
85
Last updated
2026-06-17 06:05:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405007479Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0452026-06-08
00846405007899Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB039-012026-06-08
00846405007905Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB039-052026-06-08
00846405007912Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB0392026-06-08
00846405009640Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD0392026-06-08
00846405010301Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD039-10RM2026-06-08
00846405010318Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD039-S2026-06-08
00846405011049Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0632026-06-08
00846405011056Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP063-052026-06-08
00846405011063Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP063-012026-06-08
00846405017164Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR045-10RP2026-06-08
00846405018567Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR045-HL2026-06-08
00846405021031Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR045-S2026-06-08
00846405023820Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB1192026-06-08
00846405023837Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB119-052026-06-08
00846405023844Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB119-012026-06-08
00846405023851Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD1192026-06-08
00846405023868Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD119-S2026-06-08
05700572515586Mono Mo a Hu CD117, c-kit/APC Cl 104D2AGILENT TECHNOLOGIES SINGAPORE PTE LTDC72442020-09-17
04015630971916PATHWAY Anti-c-KIT (9.7) Primary AntibodyVentana Medical Systems, Inc.50 tests2014-09-11
00847627038685CD117/c-kitBIOCARE MEDICAL LLCNPAI296T402025-04-11
B502BSB3758010CD117 (RM359)BIO SB, INC.BSB-3758-012025-03-18
B502BSB3758050CD117 (RM359)BIO SB, INC.BSB-3758-052025-03-18
B502BSB375810CD117 (RM359)BIO SB, INC.BSB-3758-12025-03-18
B502BSB3758150Tinto CD117 (RM359)BIO SB, INC.BSB-3758-152025-03-18
B502BSB375830Tinto CD117 (RM359)BIO SB, INC.BSB-3758-32025-03-18
B502BSB375870Tinto CD117 (RM359)BIO SB, INC.BSB-3758-72025-03-18
B502BSB53180Tinto CD117, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB53190CD117 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB53200CD117 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB53210CD117 RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988328814Rabbit Monoclonal Anti-Human CD117(MXR037) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-1087 10mL2024-01-31
06931988330046Rabbit Monoclonal Anti-Human CD117(MXR037) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-1087 90mL2024-01-31
06931988331371Rabbit Monoclonal Anti-Human CD117(MXR037) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-1087 0.2mL2024-01-30
06931988331432Rabbit Monoclonal Anti-Human CD117(MXR037) AntibodyFuzhou Maixin Biotech Co., Ltd.RMA-1087 1.0mL2024-01-30
05055331333292NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDCD117-032-L-U2023-07-28
05055331334091BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0007-U2023-07-28
00810113060989Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10Epitomics Inc.AC-0029A2023-06-08
00810113060996Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10Epitomics Inc.AC-0029BULK2023-06-08
00810113061016Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10Epitomics Inc.AC-00292023-06-08
00810113061030Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10Epitomics Inc.AC-0029B2023-06-08
00810119679154ANTI-CD117BIOGENEX LABORATORIESMU423-UC2023-04-25
00810119679246ANTI-C-KIT/CD117BIOGENEX LABORATORIESNU818-UC2023-04-25
00810119679543ANTI-CD117BIOGENEX LABORATORIESAM423-10M2023-04-25
00810119677549ANTI-CD117/C-KIT/SCFBIOGENEX LABORATORIESPU759-UP2023-04-21
00810119673558ANTI-CD117BIOGENEX LABORATORIESMU423-5UC2023-04-18
00810119672063ANTI-CD117/C-KIT/SCFBIOGENEX LABORATORIESAR759-5R2023-04-05
00810119671424ANTI-C-KIT/CD117BIOGENEX LABORATORIESAN818-5M2023-04-03
00810119670243ANTI-C-KIT/CD117BIOGENEX LABORATORIESAN818-5M2023-03-28
00810119670397ANTI-CD117BIOGENEX LABORATORIESAM423-5M2023-03-28
00847627007636CD117/c-kitBIOCARE MEDICAL LLCCME296AK2022-12-07
00847627007643CD117/c-kitBIOCARE MEDICAL LLCCME296BK2022-12-07
00847627007650CD117/c-kitBIOCARE MEDICAL LLCCME296CK2022-12-07
00847627008701CD117/c-kitBIOCARE MEDICAL LLCIP296G102022-12-07
00847627011985CD117/c-kitBIOCARE MEDICAL LLCPME296AA2022-12-07
00847627024565CD117/c-kitBIOCARE MEDICAL LLCOPAI296T602022-12-07
00847627029386CD117/c-kitBIOCARE MEDICAL LLCALI296G72022-12-07
00382906639820HorizonBecton, Dickinson And Company6639822020-11-11
05055331314963Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDCD117-L-CE2021-05-17
05055331325716BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA00072021-03-26
05055331325785Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDCD117-032-L-CE2021-03-26
00841683105381CD117, c-kit (YR145) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION117R-102020-12-07
00841683123781CD117, c-kit (YR145) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION117R-172020-12-07
05700571101582Poly Rb A-Hu CD117, c-kitAGILENT TECHNOLOGIES, INC.A45022020-09-17
05700572516385Mono Mo a Hu CD117, c-kit/RPE, Cl 104D2AGILENT TECHNOLOGIES SINGAPORE PTE LTDR71452020-09-17
B502BSB53160Tinto CD117 RMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB53170Tinto CD117 RMabBIO SB, INC.Predilute, 7 ml 2020-08-31
00382906638038HorizonBecton, Dickinson And Company6638032019-08-28
00615233005052Genemed®SAKURA FINETEK U.S.A., INC.61-00202019-12-28
00615233006691Genemed®SAKURA FINETEK U.S.A., INC.60-0020-72019-12-28
L502BSB5319CD117 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB5320CD117 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB5321CD117 RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00615233000811Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8267-M2502020-01-01
00615233000828Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8267-C0102020-01-01
07613336164860anti-CD117 (EP10) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.50 Test2019-12-12
10190302008549Human CD117 Purified AntibodyLIFE TECHNOLOGIES CORPORATIONCD117002018-03-06
10190302008556Human CD117 R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONCD117042018-03-06
10190302008563Human CD117 APC ConjugateLIFE TECHNOLOGIES CORPORATIONCD117052018-03-06
10190302008570Human CD117 PE-Cy®5.5 ConjugateLIFE TECHNOLOGIES CORPORATIONCD117182018-03-06