FDA.reportPublic FDA data

Glycated haemoglobin (HbA1c) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.
GUDID devices
96
Last updated
2026-07-17 21:59:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628063401161HbA1c ControlsSekisui Diagnostics, LLCSK350-QC2018-09-24
00381930737014A1CNow+ Controls™ Levels 1+2POLYMER TECHNOLOGY SYSTEMS, INC.7372019-11-15
00896863002066Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mLQUANTIMETRIX CORPORATION1510-022018-09-26
03607360047675MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2)SEBIA47672022-12-12
03607360047682MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2)SEBIA47682022-12-12
06935784430412BioHermes Glycohemoglobin Quality Control (HPLC)Wuxi Biohermes Bio & Medical Technology Co.,Ltd.BH-QC012022-01-05
06935784430429BioHermes Glycohemoglobin Quality Control (HPLC)Wuxi Biohermes Bio & Medical Technology Co.,Ltd.BH-QC012022-01-05
07070060014722Afinion HbA1c Calibration VerificationAbbott Diagnostics Technologies AS11167922019-05-31
B085K761M50Audit MicroControls Linearity FLQ HbA1cAALTO SCIENTIFICK761M-52024-01-10
03701700821205HbA1c CONTROL L+ HVITALSCIENTIFICHBAC-00492026-01-19
04560189283923Hemoglobin A1c Control SetTOSOH CORPORATIONN/A2026-01-05
00811727015853Pointe HbA1c for the BS480HORIBA INSTRUMENTS INCORPORATED14-H7546-1602020-05-28
03701700828907HbA1c CONTROL L+ HVITALSCIENTIFICHBAC-00492025-03-31
03701700829348Direct A1c Control KitVITALSCIENTIFIC551362025-03-31
B085K061M60Audit MicroControls Control FD HbA1cAALTO SCIENTIFICK061M-62018-03-27
03661540214905HbA1c CONTROL L+ HVITALSCIENTIFICHBAC-00492016-09-24
03610230005415ABX PENTRA HBA1C WB CONTROLHORIBA ABX SAS12200017042016-08-16
00884883008830MAS Diabetes Max-SP (Sample-Pack)Microgenics CorporationB400006882024-05-21
00884883008823MAS Diabetes Max, Multi-packMicrogenics CorporationB400006872024-05-20
07070060015798Afinion HbA1c Calibration VerificationAbbott Diagnostics Technologies AS11167922024-03-21
03661540304286Direct A1c Control KitELITECHGROUP INC.551362023-10-01
06935784400088BioHermes Glycohemoglobin Quality ControlWuxi Biohermes Bio & Medical Technology Co.,Ltd.A1C-GE C012022-08-26
B085K983M50Audit MicroControls Linearity FLQ HbA1c for Bio-Rad SystemsAALTO SCIENTIFICK983M-52022-03-08
03610522141685LiquichekBIO-RAD LABORATORIES, INC.120113082021-08-27
03610522141692LiquichekBIO-RAD LABORATORIES, INC.120113092021-08-27
03610522141708LiquichekBIO-RAD LABORATORIES, INC.120113102021-08-27
03610522141944LiquichekBIO-RAD LABORATORIES, INC.120113432021-08-27
03610522141951LiquichekBIO-RAD LABORATORIES, INC.120113442021-08-27
03610522141968LiquichekBIO-RAD LABORATORIES, INC.120112452021-08-27
03610522141975LiquichekBIO-RAD LABORATORIES, INC.120113342021-08-27
03610522142415LiquichekBIO-RAD LABORATORIES, INC.120113312021-08-27
06935784420062BioHermes Glycohemoglobin Quality ControlWuxi Biohermes Bio & Medical Technology Co.,Ltd.A1C-GE C012021-05-25
03610522046249InteliQBIO-RAD LABORATORIES, INC.120083092021-04-30
03610522046256InteliQBIO-RAD LABORATORIES, INC.120083102021-04-30
03610522046263InteliQBIO-RAD LABORATORIES, INC.120083112021-04-30
03610522046270InteliQBIO-RAD LABORATORIES, INC.120083122021-04-30
00811727016164Pointe HbA1c ReagentHORIBA INSTRUMENTS INCORPORATED16-H7546-2002021-01-30
04015630927333PreciControl HbA1c normRoche Diagnostics GmbH54792071902021-01-18
04015630927647PreciControl HbA1c pathRoche Diagnostics GmbH59125041902021-01-18
00850011135327ValidateLgc Clinical Diagnostics, Inc.605sa2021-01-11
00817089022805DiazymeDIAZYME LABORATORIES, INC.DZ168A-LIN2020-07-29
00817089021365DiazymeDIAZYME LABORATORIES, INC.DZ168C-CON2020-07-21
10758750006960VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68017502020-04-18
10758750006977VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68017512020-04-18
00859110005937ValidateLgc Clinical Diagnostics, Inc.6052020-03-02
00859110005944ValidateLgc Clinical Diagnostics, Inc.605to2020-03-02
05055273214758Liquid Glycated Haemoglobin (HbA1c) Control set (LIQ HbA1c CONTROL)RANDOX LABORATORIES LIMITEDHA101552020-01-22
05055273215656Liquid Glycated Haemoglobin (HbA1c) Control Level 1 (LIQ HbA1c CONTROL LEVEL 1)RANDOX LABORATORIES LIMITEDHA102242020-01-22
05055273215663Liquid Glycated Haemoglobin (HbA1c) Control Level 2 (LIQ HbA1c CONTROL LEVEL 2)RANDOX LABORATORIES LIMITEDHA102252020-01-22
09421902348006ExtendSURECANTERBURY SCIENTIFIC LIMITEDB123962018-09-20
09421902348082ExtendSURECANTERBURY SCIENTIFIC LIMITEDHB5102018-09-20
09421902348099ExtendSURECANTERBURY SCIENTIFIC LIMITEDB123972018-09-20
B085K949M50Audit MicroControls Linearity FLQ HbA1cAALTO SCIENTIFICK949M-52019-06-13
07070060014661Afinion HbA1c ControlAbbott Diagnostics Technologies AS11169752019-05-16
00380740132668AlinityAbbott GmbH08P43102019-04-08
15099590232108VigilBeckman Coulter, Inc.6500382016-08-24
B085K061M80Audit MicroControls Control FD Glycohemoglobin A1cAALTO SCIENTIFICK061M-82018-03-27
B085K067M80Audit MicroControls Control LQ HbA1cAALTO SCIENTIFICK067M-82018-03-27
B085K703M50Audit MicroControls Linearity FD HbA1cAALTO SCIENTIFICK703M-52018-03-27
05055273208818HbA1C CONTROLRANDOX LABORATORIES LIMITEDHA50722016-09-16
05391516744379Trinity BiotechPRIMUS CORPORATIONHbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 2016-09-06
05391516748087Trinity BiotechPRIMUS CORPORATIONHbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 2016-09-06
05391516748216Trinity BiotechPRIMUS CORPORATIONTri-stat Liquid Controls Kit2016-09-06
07070060006505Alere Afinion HbA1c ControlAbbott Diagnostics Technologies AS11151782018-05-07
00844509000938A1c-CellularSTRECK, INC.2111242016-09-19
00844509000945A1c-CellularSTRECK, INC.2111302016-09-19
00844509001003A1c-Cellular LinearitySTRECK, INC.2855362016-09-19
00847661000839LiquichekBIO-RAD LABORATORIES, INC.1712016-09-12
00847661000846LiquichekBIO-RAD LABORATORIES, INC.1722016-09-12
00847661000853LiquichekBIO-RAD LABORATORIES, INC.1732016-09-12
00847661000860LyphochekBIO-RAD LABORATORIES, INC.7402016-09-12
00847661002185LyphochekBIO-RAD LABORATORIES, INC.740X2016-09-12
00847661002192LiquichekBIO-RAD LABORATORIES, INC.172X2016-09-12
00847661004271LiquichekBIO-RAD LABORATORIES, INC.2912017-01-09
00847661004288LiquichekBIO-RAD LABORATORIES, INC.2922017-01-09
00847661004295LiquichekBIO-RAD LABORATORIES, INC.2932017-01-09
00847661004301LiquichekBIO-RAD LABORATORIES, INC.292X2017-01-09
00847661005698LyphochekBIO-RAD LABORATORIES, INC.120000702016-09-12
00857969006426Alfa WassermannALFA WASSERMANN, INC.C2-862017-10-10
00884883003514MAS Diabetes Liquid Assayed Diabetes ControlMicrogenics CorporationDBCL-MP2017-05-01