FDA.reportPublic FDA data

Insulin 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 insulin in a clinical specimen.
GUDID devices
35
Last updated
2026-06-13 06:05:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405003853Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob2342026-06-04
00846405003860Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob234-052026-06-04
00846405003877Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob234-012026-06-04
05055331335326BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0620-U2022-12-16
B502BSB9247CS0Insulin Control SlidesBIO SB, INC.BSB-9247-CS2025-03-18
B502BSB56950Tinto Insulin, MMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB56960Tinto Insulin, MMabBIO SB, INC.Prediluted, 15 ml 2020-06-01
B502BSB56970Insulin MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB56980Insulin MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB56990Insulin MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB68360Tinto Insulin, RMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB68370Tinto Insulin, RMabBIO SB, INC.Prediluted, 15 ml 2020-06-01
B502BSB68380Insulin RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB68390Insulin RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB68400Insulin RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB68350Tinto Insulin ,RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
00810113063270Rabbit Monoclonal Anti-Human Insulin Antibody, EP125Epitomics Inc.AC-01192023-06-08
00810113063287Rabbit Monoclonal Anti-Human Insulin Antibody, EP125Epitomics Inc.AC-0119A2023-06-08
00810113063294Rabbit Monoclonal Anti-Human Insulin Antibody, EP125Epitomics Inc.AC-0119B2023-06-08
00810113063300Rabbit Monoclonal Anti-Human Insulin Antibody, EP125Epitomics Inc.AC-0119BULK2023-06-08
00810119679024ANTI-INSULINBIOGENEX LABORATORIESMU029-UC2023-04-25
00810119674210ANTI-INSULINBIOGENEX LABORATORIESMU029-5UC2023-04-19
00810119673008ANTI-INSULINBIOGENEX LABORATORIESAM029-5M2023-04-17
05055331303912BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA06202021-05-07
05055331324061Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDINSULIN-L-U2021-05-07
05700571101186FLEX Poly Guinea Pig A-Insulin RTU (Link)AGILENT TECHNOLOGIES, INC.IR0022020-09-17
B502BSB56940Tinto Insulin MMabBIO SB, INC.Predilute, 3 ml 2020-08-31
00615233004758Genemed®SAKURA FINETEK U.S.A., INC.61-00392019-12-28
00615233006585Genemed®SAKURA FINETEK U.S.A., INC.60-0039-72019-12-28
L502BSB5697Insulin MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB5698Insulin MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB5699Insulin MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
L502BSB6838Insulin RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB6839Insulin RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB6840Insulin RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16