FDA.reportPublic FDA data

Coagulation factor VIII 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 coagulation factor VIII in a clinical specimen.
GUDID devices
34
Last updated
2026-06-16 06:05:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405001781Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob3212026-06-05
00846405001798Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob321-052026-06-05
00846405001804Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob321-012026-06-05
00846405003310Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob1962026-06-05
00846405003327Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob196-052026-06-05
00846405003334Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob196-012026-06-05
00846405006151Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1412026-06-05
00846405006700Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0192026-06-05
00846405007523Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0142026-06-05
00846405007530Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0542026-06-05
00846405011223Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0122026-06-05
00846405011230Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP012-052026-06-05
00846405011247Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP012-012026-06-05
00846405011254Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP1032026-06-05
00846405011261Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP103-052026-06-05
00846405011278Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP103-012026-06-05
00846405017416Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM019-HL2026-06-05
00846405018260Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM141-HL2026-06-05
00846405021796Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM019-S2026-06-05
00846405021802Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR014-S2026-06-05
00846405021819Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR054-S2026-06-05
00846405022373Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM141-S2026-06-05
00846405024391Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM019-252026-06-05
00846405025565Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob196-BLK2026-06-05
00846405025664Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP012-BLK2026-06-05
00198815000107Recombinant Factor VIII Substrate, Porcine SequenceTakeda Pharmaceuticals U.S.A., Inc.65217532025-08-01
00810170553172IHCSlmp, LLC(BTO) Factor VIII Related Antigen/V (F8/86) Antibo2025-03-14
00810170553189IHCSlmp, LLC(BTO) Sample FactorXIII-A (AC-1A1) Antibody (2ml)2025-03-14
00810170553516IHCSlmp, LLC(BTO) Sample RTU Factor XIIIa Rabbit Polyclonal An2025-03-14
00810170552182IHCSlmp, LLC(BTO) RTU Factor XIIIa Rabbit Polyclonal Antibody 2025-03-06
00810170552199IHCSlmp, LLC(BTO) RTU Factor XIIIa Rabbit Polyclonal Antibody 2025-03-06
00810170551475IHCSlmp, LLCRTU Factor VIII Related Antigen/V (F8/86) Antibody2025-03-05
00810170551482IHCSlmp, LLC(BTO) Manual RTU Factor VIII Related Antigen/V (F82025-03-05
00810170551499IHCSlmp, LLCRTU FactorXIII-A (AC-1A1) Antibody (10ml)2025-03-05