FDA.reportPublic FDA data

Galectin-3 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 galectin-3 protein in a clinical specimen.
GUDID devices
44
Last updated
2026-06-16 06:05:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405003433Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob5412026-06-05
00846405003440Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob541-052026-06-05
00846405003457Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob541-012026-06-05
00846405006748Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM541-252026-06-05
00846405006755Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5412026-06-05
00846405018406Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM541-HL2026-06-05
00846405021833Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM541-S2026-06-05
05055331334701BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0238-U2022-12-16
B502BSB55410Tinto Galectin-3, MMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB55430Galectin-3 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB55440Galectin-3 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB55450Galectin-3 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329156Mouse Monoclonal Anti-Human Galectin-3(MX060) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0835 10mL2024-01-31
06931988330367Mouse Monoclonal Anti-Human Galectin-3(MX060) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0835 90mL2024-01-31
06931988308489Mouse Monoclonal Anti-Human Galectin-3(MX060) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0835 1.0mL2024-01-25
06931988308472Mouse Monoclonal Anti-Human Galectin-3(MX060) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0835 0.2mL2024-01-23
00850036867777Q-STAIN® QSX-Enh-P Gal-3NOVODIAX, INC.QP32025-0042023-11-21
00850036867784Q-STAIN® QSX-Enh-F Gal-3NOVODIAX, INC.QF32025-0042023-11-21
00810113069616Rabbit Monoclonal Anti-Human Galectin-3, EP412Epitomics Inc.AC-0361BULK2023-06-22
00810113069630Rabbit Monoclonal Anti-Human Galectin-3, EP412Epitomics Inc.AC-0361A2023-06-22
00810113069647Rabbit Monoclonal Anti-Human Galectin-3, EP412Epitomics Inc.AC-0361B2023-06-22
00810113069623Rabbit Monoclonal Anti-Human Galectin-3, EP412Epitomics Inc.AC-03612023-06-13
00841683130680Galectin-3 (9C4) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION255M-142022-11-14
00841683130697Galectin-3 (9C4) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION255M-152022-11-14
00841683130703Galectin-3 (9C4) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION255M-162022-11-14
00850030934772ihcDirect® Galectin-3 Ab Conjugate 5mLNOVODIAX, INC.H32025-R0052021-08-20
00850030934789ihcDirect® Galectin-3 Ab Conjugate 15mLNOVODIAX, INC.H32025-R0152021-08-20
00850030934796ihcDirect® Galectin-3 Ab-Enh 5mLNOVODIAX, INC.K47025-0052021-08-20
00850030934802ihcDirect® Galectin-3 Ab-Enh 15mLNOVODIAX, INC.K47025-0152021-08-20
05055331317902BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA02382021-05-17
00841683100515Galectin-3 (9C4) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-42562021-04-15
00850000596788ihcDirect® Galectin-3 Ab, 5mLNOVODIAX, INC.K32025-0052020-12-22
00850000596795ihcDirect® Galectin-3 Ab, 15mLNOVODIAX, INC.K32025-0152020-12-22
00850000596801ihcDirect® Galectin-3 Ab-Enh, 5mLNOVODIAX, INC.K47025-0052020-12-22
00850000596818ihcDirect® Galectin-3 Ab-Enh, 15mLNOVODIAX, INC.K47025-0152020-12-22
B502BSB55400Tinto Galectin-3 MMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB55420Tinto Galectin-3 MMabBIO SB, INC.Predilute, 15 ml2020-08-31
00841683130710Galectin-3 (9C4) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION255M-172020-08-07
00841683130727Galectin-3 (9C4) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION255M-182020-08-07
00615233006134Genemed®SAKURA FINETEK U.S.A., INC.60-0133-72019-12-28
L502BSB5543Galectin-3 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB5544Galectin-3 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB5545Galectin-3 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00615233003713Genemed®SAKURA FINETEK U.S.A., INC.61-0133-22020-02-16