FDA.reportPublic FDA data

Amyloid A component 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 amyloid A component in a clinical specimen.
GUDID devices
34
Last updated
2026-08-12 10:10:45

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05700572005339Mono Mo A-Hu Amyloid A Cl mc1AGILENT TECHNOLOGIES SINGAPORE PTE LTDM07592020-09-17
00846405002054Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4102026-06-05
00846405002061Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob410-052026-06-05
00846405002078Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob410-012026-06-05
00846405004423Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob0032026-06-05
00846405004430Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob003-052026-06-05
00846405004447Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob003-012026-06-05
00846405007059Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1182026-06-05
00846405010837Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP1232026-06-05
00846405010844Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP123-052026-06-05
00846405010851Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP123-012026-06-05
00846405013104Diagnostic BioSystemsDiagnostic Biosystems, Inc.KT0082026-06-05
00846405015924Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR1782026-06-05
00846405015931Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR178-S2026-06-05
00846405020836Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM118-S2026-06-05
00846405020843Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM118-252026-06-05
00846405024674Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR178-252026-06-05
00810170552281IHCSlmp, LLC(BTO) Sample Amyloid A Component Antibody (2ml)2025-03-07
00810170550218IHCSlmp, LLC(BTO) Amyloid A Component (MC1) Antibody (10ml)2025-03-03
00810170550225IHCSlmp, LLC(BTO) Manual Amyloid A Component (MC1) Antibody (62025-03-03
B502BSB28030Tinto Amyloid A, RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB28040Tinto Amyloid A, RMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB28050Tinto Amyloid A, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB28060Amyloid A RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB28070Amyloid A RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB28080Amyloid A RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
00847627006264Amyloid ABIOCARE MEDICAL LLCCM125A2022-12-07
00847627011084Amyloid ABIOCARE MEDICAL LLCPM125AA2022-12-07
05700572030218FLEX Mono Mo A-Hu Amyloid A Cl mc1 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6052020-09-17
05700572030331FLEX Mono Mo A-Hu Amyloid A Cl mc1 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6052020-09-17
05700572034179FLEX Mono Mo A-Hu Amyloid A Cl mc1 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6052020-09-17
L502BSB2806Amyloid A RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB2807Amyloid A RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB2808Amyloid A RMabBIO SB, INC.Concentrate, 1 ml2020-03-16