FDA.reportPublic FDA data

Prostate-specific membrane antigen (PSMA) 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 prostate-specific membrane antigen (PSMA), also known as glutamate carboxypeptidase 2, in a clinical specimen.
GUDID devices
55
Last updated
2026-06-16 06:05:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405000197Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4402026-06-05
00846405000203Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob440-052026-06-05
00846405000210Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob440-012026-06-05
00846405014279Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob440R2026-06-05
00846405014286Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob440R-012026-06-05
00846405014293Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob440R-052026-06-05
00846405015382Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5812026-06-05
00846405015399Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM581R2026-06-05
00846405015405Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM581R-S2026-06-05
00846405015412Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM581-S2026-06-05
00846405024247Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM581-252026-06-05
B502BSB63470Tinto PSMA, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB63480PSMA RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB63490PSMA RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB63500PSMA RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329613Mouse Monoclonal Anti-Human PSMA(MX095) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0887 10mL2024-02-01
06931988330657Mouse Monoclonal Anti-Human PSMA(MX095) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0887 90mL2024-02-01
06931988320245Mouse Monoclonal Anti-Human PSMA(MX095) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0887 1.0mL2024-01-26
06931988320238Mouse Monoclonal Anti-Human PSMA(MX095) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0887 0.2mL2024-01-24
00810138720219Rabbit Monoclonal Anti-Human PSMA (EP192)Epitomics Inc.AC-0160CMBULK2023-07-31
05055331335081BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0431-U2023-07-28
05055331335746NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDPSA-431-L-U2023-07-28
00810113064246Rabbit Monoclonal Anti-Human PSMA Antibody, EP192Epitomics Inc.AC-0160BULK2023-06-09
00810113064253Rabbit Monoclonal Anti-Human PSMA Antibody, EP192Epitomics Inc.AC-0160A2023-06-09
00810113064260Rabbit Monoclonal Anti-Human PSMA Antibody, EP192Epitomics Inc.AC-01602023-06-09
00810113064277Rabbit Monoclonal Anti-Human PSMA Antibody, EP192Epitomics Inc.AC-0160B2023-06-09
00810119672940ANTI-PSMABIOGENEX LABORATORIESAN714-5M2023-04-07
00841683119609PSA (EP109) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION324R-182022-12-07
00841683119647PSA (EP109) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION324R-162022-12-07
00841683119890PSA (EP109) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION324R-142022-12-07
00841683136217PSA (ER-PR8) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION324M-152022-12-07
00841683136231PSA (ER-PR8) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION324M-162022-12-07
00841683136255PSA (ER-PR8) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION324M-172022-12-07
00841683136279PSA (ER-PR8) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION324M-182022-12-07
00841683144038PSA (EP109) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION324R-172022-12-07
00841683144045PSA (EP109) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION324R-152022-12-07
04015630971206CONFIRM® anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary AntibodyVentana Medical Systems, Inc.052669390012022-12-07
00841683102885PSMA (EP192) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION327R-182022-11-14
00841683103059PSMA (EP192) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION327R-172022-11-14
00841683106647PSMA (EP192) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION327R-142022-11-14
00841683108511PSMA (EP192) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION327R-152022-11-14
00841683108801PSMA (EP192) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION327R-162022-11-14
00841683143642PSMA (EP192) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION760-60762021-04-15
05055331304117BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA04312021-04-02
05055331325723Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDPSA-431-L-CE2021-04-02
05700571102473Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3E6AGILENT TECHNOLOGIES, INC.M36202020-09-17
05700571107126Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3E6AGILENT TECHNOLOGIES, INC.M36202020-09-17
05700571107201FLEX Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3E6 RTU (Link)AGILENT TECHNOLOGIES, INC.IR0892020-09-17
00841683100591PSA (ER-PR8) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-42712020-09-15
B502BSB63450Tinto PSMA RMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB63460Tinto PSMA RMabBIO SB, INC.Predilute, 7 ml 2020-08-31
00841683136194PSA (ER-PR8) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION324M-142020-08-07
L502BSB6348PSMA RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB6349PSMA RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB6350PSMA RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16