FDA.reportPublic FDA data

Mammaglobin 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 mammaglobin protein in a clinical specimen.
GUDID devices
49
Last updated
2026-09-14 22:39:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841683151432Mammaglobin 31A5 Rab.CELL MARQUE CORPORATIONPA08022026-09-04
00846405006588Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM544-252026-06-05
00846405006595Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5442026-06-05
00846405009039Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB036-052026-06-05
00846405009046Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB0362026-06-05
00846405010066Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD0362026-06-05
00846405010660Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD036-S2026-06-05
00846405018413Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM544-HL2026-06-05
00846405020492Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMAB036-012026-06-05
00846405022045Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM544-S2026-06-05
00846405024872Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM544-1002026-06-05
00846405025817Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD036-252026-06-05
00846405025824Diagnostic BioSystemsDiagnostic Biosystems, Inc.RMPD036-HL2026-06-05
05055331334978BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0378-U2022-12-16
00847627042071Mammaglobin (M)BIOCARE MEDICAL LLCNPAI269T402025-11-25
B502BSB57440Tinto Mammaglobin, RMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB57450Tinto Mammaglobin, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB57460Mammaglobin RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB57470Mammaglobin RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB57480Mammaglobin RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00615233008374Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8240-M2502023-06-16
00810113065564Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249Epitomics Inc.AC-0219B2023-06-15
00810113065571Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249Epitomics Inc.AC-0219BULK2023-06-15
00810113065625Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249Epitomics Inc.AC-0219LCBULK2023-06-15
00810113065632Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249Epitomics Inc.AC-0219CMBULK2023-06-15
00810113065540Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249Epitomics Inc.AC-02192023-06-13
00810113065557Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249Epitomics Inc.AC-0219A2023-06-13
00841683107217Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION280R-102022-11-14
00841683132561Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal AntibodiesCELL MARQUE CORPORATION280C-142022-11-14
00841683132585Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal AntibodiesCELL MARQUE CORPORATION280C-152022-11-14
00841683132622Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal AntibodiesCELL MARQUE CORPORATION280C-172022-11-14
00841683132646Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal AntibodiesCELL MARQUE CORPORATION280C-182022-11-14
00841683132660Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION280R-142022-11-14
00841683132684Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION280R-152022-11-14
00841683132707Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION280R-162022-11-14
00841683132721Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION280R-172022-11-14
00841683132745Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION280R-182022-11-14
05055331325259BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA03782021-05-07
00841683100560Mammaglobin (31A5) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATION760-42632021-04-15
05700571101230FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Link)AGILENT TECHNOLOGIES, INC.IR0742020-09-17
05700571101360DakoAGILENT TECHNOLOGIES, INC.IS0742020-09-17
05700571102527Mono Mo A-Hu Mammaglobin Cl 304-1A5AGILENT TECHNOLOGIES, INC.M36252020-09-17
05700571107034FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis)AGILENT TECHNOLOGIES, INC.GA0742020-09-17
B502BSB57430Tinto Mammaglobin RMabBIO SB, INC.Predilute, 3 ml 2020-08-31
00841683132608Mammaglobin Cocktail (304-1A5 & 31A5) Mouse & Rabbit Cocktail AntibodyCELL MARQUE CORPORATION280C-162020-08-21
L502BSB5746Mammaglobin RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB5747Mammaglobin RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB5748Mammaglobin RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00615233008305Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8240-C0102020-03-03