FDA.reportPublic FDA data

Mesothelin 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 mesothelin in a clinical specimen.
GUDID devices
38
Last updated
2026-06-17 06:05:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405009565Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB1072026-06-08
00846405009572Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB107-052026-06-08
00846405009589Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB107-012026-06-08
00846405010264Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD107-252026-06-08
00846405010271Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD1072026-06-08
00846405017881Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD107-HL2026-06-08
00846405022069Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD107-S2026-06-08
05055331334947BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0373-U2022-12-16
B502BSB69190Tinto Mesothelin, RMabBIO SB, INC.Predilute, 3 ml2020-06-01
B502BSB69200Tinto Mesothelin, RMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB69210Tinto Mesothelin, RMabBIO SB, INC.Prediluted, 15 ml2020-06-01
B502BSB69220Mesothelin RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB69230Mesothelin RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB69240Mesothelin RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
05055331333964NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDMESO-L-U2023-07-28
00810113063485Rabbit Monoclonal Anti-Human Mesothelin Antibody, EP140Epitomics Inc.AC-01302023-06-09
00810113063508Rabbit Monoclonal Anti-Human Mesothelin Antibody, EP140Epitomics Inc.AC-0130A2023-06-09
00810113063515Rabbit Monoclonal Anti-Human Mesothelin Antibody, EP140Epitomics Inc.AC-0130B2023-06-09
00810113063522Rabbit Monoclonal Anti-Human Mesothelin Antibody, EP140Epitomics Inc.AC-0130BULK2023-06-09
00810119675538ANTI-MESOTHELINBIOGENEX LABORATORIESMU433-UC2023-05-05
00810119678027ANTI-MESOTHELINBIOGENEX LABORATORIESAM433-10M2023-04-24
00810119673862ANTI-MESOTHELINBIOGENEX LABORATORIESMUA09-UC2023-04-18
00810119671653ANTI-MESOTHELINBIOGENEX LABORATORIESAM433-5M2023-04-03
00841683122098Mesothelin (EP140) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION439R-142022-11-14
00841683122104Mesothelin (EP140) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION439R-152022-11-14
00841683122111Mesothelin (EP140) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION439R-172022-11-14
00841683122128Mesothelin (EP140) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION439R-182022-11-14
00841683142638Mesothelin (EP140) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION439R-162022-11-14
00847627003461MesothelinBIOCARE MEDICAL LLCACI3175A2022-09-23
00847627003478MesothelinBIOCARE MEDICAL LLCACI3175B2022-09-23
00847627004604MesothelinBIOCARE MEDICAL LLCAPI3175AA2022-09-23
05055331304209BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA03732021-03-26
05055331306487Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDMESO-L-CE2021-03-26
07613336153529VENTANA MSLN (SP74) Dx AssayVentana Medical Systems, Inc.083245570012021-02-03
07613336160596VENTANA MSLN (SP74) AssayVentana Medical Systems, Inc.085080110012021-02-03
L502BSB6922Mesothelin RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB6923Mesothelin RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB6924Mesothelin RMabBIO SB, INC.Concentrate, 1 ml2020-03-16