FDA.reportPublic FDA data

MLH1 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 MLH1 antigen in a clinical specimen.
GUDID devices
42
Last updated
2025-09-04 13:55:59

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05700575005213MLH1 IHC pharmDx (Dako Omnis)AGILENT TECHNOLOGIES, INC.GE0792025-08-27
00847627037428MLH-1BIOCARE MEDICAL LLCNPAI220T402025-06-20
00847627037466MLH-1BIOCARE MEDICAL LLCNPAI220T802025-06-20
B502BSB3787010MLH1 (RBT-MLH1)BIO SB, INC.BSB-3787-012025-03-18
B502BSB3787050MLH1 (RBT-MLH1)BIO SB, INC.BSB-3787-052025-03-18
B502BSB378710MLH1 (RBT-MLH1)BIO SB, INC.BSB-3787-12025-03-18
B502BSB3787150Tinto MLH1 (RBT-MLH1)BIO SB, INC.BSB-3787-152025-03-18
B502BSB378730Tinto MLH1 (RBT-MLH1)BIO SB, INC.BSB-3787-32025-03-18
B502BSB378770Tinto MLH1 (RBT-MLH1)BIO SB, INC.BSB-3787-72025-03-18
B502BSB57640Tinto MLH1, MMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB57670MLH1 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB57680MLH1 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB57690MLH1 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329354Mouse Monoclonal Anti-Human MLH1(MX063) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0838 10mL2024-02-01
06931988331234Mouse Monoclonal Anti-Human MLH1(MX063) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0838 90mL2024-02-01
06931988308663Mouse Monoclonal Anti-Human MLH1(MX063) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0838 1.0mL2024-01-26
06931988308656Mouse Monoclonal Anti-Human MLH1(MX063) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0838 0.2mL2024-01-25
05055331333971NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDMLH1-L-U2023-07-28
05055331336729BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0988-X2022-12-16
05700573003730FLEX Mono Mo A-Hu MLH1, Cl ES05 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA0792023-04-28
00810119678959ANTI-MLH 1BIOGENEX LABORATORIESAM703-10M2023-04-24
00810119670847ANTI-MLH 1BIOGENEX LABORATORIESAM703-5M2023-03-31
05055331335906BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0988-U2023-03-03
05055331328847BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA09882022-12-07
00847627008893MLH-1BIOCARE MEDICAL LLCIPI220G102022-09-23
00847627027214MLH-1BIOCARE MEDICAL LLCALI220G72022-09-23
05055331306296Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDMLH1-L-CE2021-03-26
05055331318060BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA06102021-03-26
04015630984008anti-MLH-1 (M1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.064729660012021-02-03
05700571105443Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05AGILENT TECHNOLOGIES, INC.M36402020-09-17
05700571105450Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05AGILENT TECHNOLOGIES, INC.M36402020-09-17
05700571105481FLEX Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 RTU (Link)AGILENT TECHNOLOGIES, INC.IR0792020-09-17
05700571105498FLEX Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 RTUAGILENT TECHNOLOGIES, INC.IS0792020-09-17
B502BSB57650Tinto MLH1 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB57660Tinto MLH1 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
00615233004161Genemed®SAKURA FINETEK U.S.A., INC.61-00792019-12-28
00615233006356Genemed®SAKURA FINETEK U.S.A., INC.60-0079-72019-12-28
L502BSB5767MLH1 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB5768MLH1 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB5769MLH1 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00615233001573Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8324-M2502020-01-01
00615233001580Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8324-C0102020-01-01