FDA.reportPublic FDA data

Synaptophysin 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 synaptophysin in a clinical specimen.
GUDID devices
94
Last updated
2026-06-16 06:05:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405005291Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob3992026-06-06
00846405005307Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob399-052026-06-06
00846405005314Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob399-012026-06-06
00846405009084Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB0182026-06-06
00846405009091Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB018-052026-06-06
00846405009107Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB018-012026-06-06
00846405010097Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD0182026-06-06
00846405015627Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5922026-06-06
00846405015634Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM592-S2026-06-06
00846405018628Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD018-HL2026-06-06
00846405019960Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD018-10RM2026-06-06
00846405022793Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD018-S2026-06-06
00847627033918Synaptophysin BIOCARE MEDICAL LLCALI371G72022-12-22
05055331334817BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0299-U2022-12-16
00847627037787SynaptophysinBIOCARE MEDICAL LLCNPAI371T402025-03-20
B502BSB3775150TintoFast Synaptophysin (Polyclonal)BIO SB, INC.BSB-3775-152025-03-18
B502BSB377530TintoFast Synaptophysin (Polyclonal)BIO SB, INC.BSB-3775-32025-03-18
B502BSB377570TintoFast Synaptophysin (Polyclonal)BIO SB, INC.BSB-3775-72025-03-18
B502BSB3811010Synaptophysin (RBT-Synaptophysin)BIO SB, INC.BSB-3811-012025-03-18
B502BSB3811050Synaptophysin (RBT-Synaptophysin)BIO SB, INC.BSB-3811-052025-03-18
B502BSB381110Synaptophysin (RBT-Synaptophysin)BIO SB, INC.BSB-3811-12025-03-18
B502BSB3811150Tinto Synaptophysin (RBT-Synaptophysin)BIO SB, INC.BSB-3811-152025-03-18
B502BSB381130Tinto Synaptophysin (RBT-Synaptophysin)BIO SB, INC.BSB-3811-32025-03-18
B502BSB381170Tinto Synaptophysin (RBT-Synaptophysin)BIO SB, INC.BSB-3811-72025-03-18
00810170553394IHCSlmp, LLC(BTO) Sample Synaptophysin (SP11) Antibody (2ml)2025-03-14
00810170551949IHCSlmp, LLC(BTO) RTU Synaptophysin (SP11) Antibody (10ml)2025-03-06
B502BSB22370Tinto Synaptophysin ,RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB22380Tinto Synaptophysin, RMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB22390Tinto Synaptophysin, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB22400Synaptophysin RMabBIO SB, INC.Concentrate, 0.1 ml 2020-02-29
B502BSB22410Synaptophysin RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB22420Synaptophysin RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB59470Tinto Synaptophysin, RPabBIO SB, INC.Predilute, 15 ml2020-06-01
B502BSB59480Synaptophysin RPabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB59490Synaptophysin RPabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB59500Synaptophysin RPabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329712Mouse Monoclonal Anti-Human Synaptophysin (MX038) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0742 10mL2024-01-31
06931988330428Mouse Monoclonal Anti-Human Synaptophysin (MX038) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0742 90mL2024-01-31
06931988305068Mouse Monoclonal Anti-Human Synaptophysin (MX038) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0742 1.0mL2024-01-26
06931988305051Mouse Monoclonal Anti-Human Synaptophysin (MX038) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0742 0.2mL2024-01-23
05055331335791NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDSYNAP-299-L-U2023-07-28
00810113064284Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158Epitomics Inc.AC-0163A2023-06-09
00810113064291Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158Epitomics Inc.AC-0163B2023-06-09
00810113064307Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158Epitomics Inc.AC-01632023-06-09
00810113064314Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158Epitomics Inc.AC-0163BULK2023-06-09
00850646007235Anti-SynaptophysinBIOGENEX LABORATORIESAM363-5M2023-05-08
00810119675514ANTI-SYNAPTOPHYSINBIOGENEX LABORATORIESMU363-UC2023-05-05
00810119676948ANTI-SYNAPTOPHYSINBIOGENEX LABORATORIESAM363-10M2023-05-04
00810119676689ANTI-SYNAPTOPHYSINBIOGENEX LABORATORIESAX363-YCD2023-04-20
00810119673770ANTI-SYNAPTOPHYSINBIOGENEX LABORATORIESMU363-5UC2023-04-18
00810119671264ANTI-SYNAPTOPHYSINBIOGENEX LABORATORIESAN857-5M2023-03-31
00810119670076ANTI-SYNAPTOPHYSINBIOGENEX LABORATORIESAM363-5M2023-03-28
00841683104636Synaptophysin (EP158) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION336R-162022-11-14
00841683105183Synaptophysin (EP158) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION336R-142022-11-14
00841683121336Synaptophysin (MRQ-40) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION336R-962022-11-14
00841683121343Synaptophysin (MRQ-40) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION336R-982022-11-14
00841683123743Synaptophysin (EP158) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION336R-152022-11-14
00841683136835Synaptophysin Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION336A-702022-11-14
00841683136842Synaptophysin Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION336A-742022-11-14
00841683136859Synaptophysin Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION336A-752022-11-14
00841683136866Synaptophysin Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION336A-762022-11-14
00841683136873Synaptophysin Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION336A-772022-11-14
00841683136880Synaptophysin Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION336A-782022-11-14
00841683136897Synaptophysin (MRQ-40) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION336R-942022-11-14
00841683136903Synaptophysin (MRQ-40) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION336R-952022-11-14
00841683136910Synaptophysin (MRQ-40) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION336R-972022-11-14
00850036867258Q-STAIN® QSX-Enh-F SYN NOVODIAX, INC.QF32034-0042022-07-21
00850036867371Q-STAIN® QSX-Enh-P SYNNOVODIAX, INC.QP32034-0042022-07-21
00850030934215ihcDirect® Synaptophysin Ab Conjugate 5mLNOVODIAX, INC.H32034-R0052021-08-20
00850030934222ihcDirect® Synaptophysin Ab Conjugate 15mLNOVODIAX, INC.H32034-R0152021-08-20
05055331301352Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDSYNAP-299-L-CE2021-04-30
05055331304339BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA02992021-04-30
00841683101246Synaptophysin (MRQ-40) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION760-45952021-04-15
04015630972463CONFIRM anti-Synaptophysin [SP11] Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.054793040012021-01-29
00841683104612Synaptophysin (EP158) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION336R-172020-12-07
00841683104629Synaptophysin (EP158) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION336R-182020-12-07
00850000596740ihcDirect® Synaptophysin Ab, 5mLNOVODIAX, INC.K32034-0052020-10-26
00850000596757ihcDirect® Chromogranin A Ab, 15mLNOVODIAX, INC.K32034-0152020-10-26
05700572033714Mono Mo A-Hu Synaptophysin Cl DAK-SYNAPAGILENT TECHNOLOGIES SINGAPORE PTE LTDM73152020-09-17
05700572034490FLEX Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6602020-09-17