FDA.reportPublic FDA data

Glucose IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
GUDID devices
242
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00015482500054Assure® Dose Normal (Level 1) Control SolutionARKRAY USA, INC.5000052019-01-15
00015482530068Assure® Prism Control SolutionARKRAY USA, INC.5300062019-01-22
00015482540050GLUCOCARD® Shine Level 1 Control Solution ARKRAY USA, INC.5400052019-01-22
00015482540074GLUCOCARD® Shine Level 2 Control SolutionARKRAY USA, INC.5400072019-01-22
00015482570002GLUCOCARD® Expression™ Level 1 Control SolutionARKRAY USA, INC.5700052018-09-25
00015482570071GLUCOCARD® Expression™ Level 2 Control SolutionARKRAY USA, INC.5700072018-09-25
00015482720056GLUCOCARD® 01 ControlARKRAY USA, INC.7200052019-08-01
00015482740061GLUCOCARD® 01 ControlARKRAY USA, INC.7400062019-08-01
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.TRUEcontrol Solution Level 12021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.TRUEcontrol Solution Level 02021-01-29
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 12020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 22020-10-21
00021292008413TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 32020-10-21
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.TRUE FOCUS Control Solution Level 12021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.TRUE FOCUS Control Solution Level 22021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.TRUE FOCUS Control Solution Level 32021-02-26
00021292015091TRUENESSTRIVIDIA HEALTH, INC.TRUENESS Control Solution2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.TRUENESS Control Solution2024-04-03
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 12025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 22025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 32025-10-02
00096295129182LEADERCardinal Health 110, Inc.52773062017-04-24
00353885012645OneTouch Ultra PlusLifeScan Europe GmbH024-2722022-08-31
00353885012683OneTouch Ultra PlusLifeScan Europe GmbH024-2822022-08-31
00384840533103Prodigy Control Solution LowProdigy Diabetes Care, LLC0533102016-09-22
00384840533509Prodigy Control Solution HighProdigy Diabetes Care, LLC0533502016-09-22
00384849903105Prodigy Control Solution LowProdigy Diabetes Care, LLC9903102016-09-22
00385543764023AgaMatrixAgaMatrix, Inc.8000-037642016-11-04
00389154000440GL GoodLife Glucose Control Solution(Level 1)HMD BIOMEDICAL INC.GL GCS2017-10-30
00389167362108UniStrip Control Solution LowUnistrip Technologies, LLC0362102016-09-23
00810008210987ONE-CAREMediVena, LLCAC500 2023-09-10
00810128750059CareTouchTianjin Empecs Medical Device Co.,LtdCT2-32023-01-13
00840423500035VivaGuard Ino Control SolutionABOUND Diagnostics, Inc.VGC01-3732025-06-06
00850027494302Easy Talk/PlusII Control Solution LOWHOME AIDE DIAGNOSTICS, INC.ET-PIICTR2024-06-14
00850027494319Easy Talk/PlusII Control Solution HIGHHOME AIDE DIAGNOSTICS, INC.ET-PIICTR2024-06-14
00850031608696GlucertainCELLERA LLC301852023-03-28
00856276008826GlucertainCELLERA LLC301902018-11-06
00859519002056BioTel Care® Double Control Solution TELCARE, LLCCS2019-03-11
00883489001795GEBIONIME CORPORATIONGE3332019-03-25
00883489001818GEBIONIME CORPORATIONGE3332019-03-25
00883489002495SMARTMETERBIONIME CORPORATIONGC5502023-12-15
00883489002631RIGHTEST Control Solution GC700BIONIME CORPORATIONGC7002025-10-17
00885017000553EasyMax NHCS Set ENEPS BIO TECHNOLOGY CORP.EasyMax2020-06-23
00885017000560EasyMax 15 NHCS Set ENEPS BIO TECHNOLOGY CORP.EM442020-06-23
00885017000638EM 15 Blood Glucose Level 2 Control SolutionEPS BIO TECHNOLOGY CORP.EM442019-07-19
00891237001201Easy Step Control Solution - NORMALHOME AIDE DIAGNOSTICS, INC.T506-642016-10-26
00891237001225Easy Step Control Solution - LOWHOME AIDE DIAGNOSTICS, INC.T506-652016-05-01
00891237001232Easy Step Control Solution - HIGHHOME AIDE DIAGNOSTICS, INC.T506-662016-05-01
00891237001454Easy Trak Control Solution - HIGHHOME AIDE DIAGNOSTICS, INC.1000400062016-05-01
00891237001461Easy Trak Control Solution - LOWHOME AIDE DIAGNOSTICS, INC.1000400052016-05-01
00891237001492Easy Talk Control Solution - LOWHOME AIDE DIAGNOSTICS, INC.GOD112016-05-01
00891237001676Easy Plus II Control Solution - LOWHOME AIDE DIAGNOSTICS, INC.GOD112016-05-01
00891237001683Easy Plus II Control Solution - HIGHHOME AIDE DIAGNOSTICS, INC.GOD312016-05-01
04719869703149TysonBio AC500 Control Solution (Level 1)TYSON BIORESEARCH INC.AC5002020-04-15
04719869703156TysonBio AC500 Control Solution (Level 2)TYSON BIORESEARCH INC.AC5002020-04-15
04719869703163TysonBio AC500 Control Solution (Level 3)TYSON BIORESEARCH INC.AC5002020-04-15
04719869704160Tyson Bio HT100-B Control Solution Level 3TYSON BIORESEARCH INC.HT100-B2023-02-17
04719869704177Tyson Bio HT100-B Control Solution Level 2TYSON BIORESEARCH INC.HT100-B2023-02-17
04719869704184Tyson Bio HT100-B Control Solution Level 1TYSON BIORESEARCH INC.HT100-B2023-02-17
04719869705853Tyson Bio HS100 Control Solution (Level 1)TYSON BIORESEARCH INC.HS1002024-12-04
04719869705860Tyson Bio HS100 Control Solution (Level 2)TYSON BIORESEARCH INC.HS1002024-12-04
04719869705877Tyson Bio HS100 Control Solution (Level 3)TYSON BIORESEARCH INC.HS1002024-12-04
08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.GlucoTrol-NG Level 32020-10-08
08718734960607Eurotrol GlucoTrol-NG Eurotrol B.V.GlucoTrol-NG Level 42020-10-08
10301931489016BREEZE® 2ASCENSIA DIABETES CARE US INC.1489A2016-09-16
10301931490012BREEZE® 2ASCENSIA DIABETES CARE US INC.1490A2016-09-16
10301931491019BREEZE® 2ASCENSIA DIABETES CARE US INC.1491A2016-09-16
10301937109017CONTOUR®ASCENSIA DIABETES CARE US INC.7109B2016-09-16
10301937110013CONTOUR®ASCENSIA DIABETES CARE US INC.7110B2016-09-16
10301937111010CONTOUR®ASCENSIA DIABETES CARE US INC.7111B2016-09-16
10301937314015CONTOUR® NEXTASCENSIA DIABETES CARE US INC.73142016-09-16
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONNova Primary Ampuled Control 1, 22023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONNova Primary Linearity Level 1 2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONNova Primary Linearity Level 22023-02-24
10385541003305AgaMatrixAgaMatrix, Inc.8000-105192016-11-04
10385541003503AgaMatrixAgaMatrix, Inc.8000-105202016-11-04
10385542013013AgaMatrixAgaMatrix, Inc.8000-020132016-11-04
10612479212807McKessonMCKESSON MEDICAL-SURGICAL INC.50522016-12-09
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution - Level 1 and Level 32025-11-25
00860003164594RosieSouthern Life Systems, Inc.RealTime2026-03-02