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
163
Last updated
2026-03-10 22:50:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860003164594RosieSouthern Life Systems, Inc.RealTime2026-03-02
00810079240593Teladoc Health, Inc.Teladoc Health, Inc.BG5002026-02-17
00860015091659KetoBMKETOBM USA LLCKBM-GCL12026-01-19
00860015091666KetoBMKETOBM USA LLCKBM-GCL22026-01-19
30840330706545TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution - Level 1 and Level 32025-11-25
00015482510060Assure® Control - Control Solution Level 2 & Level 3ARKRAY USA, INC.5100062025-09-26
00810079240142LivongoLIVONGO HEALTH, INCBG300 - MX2025-09-25
00810079240463Teladoc Health, Inc.Teladoc Health, Inc.BG300 - CH2025-09-25
00810079240470Teladoc Health, Inc.Teladoc Health, Inc.BG300 - MX2025-09-25
10385541335017AgaMatrixAgaMatrix, Inc.8000-013352016-11-04
20385541003203AgaMatrixAgaMatrix, Inc.8000-105192016-11-04
20385541003401AgaMatrixAgaMatrix, Inc.8000-105202016-11-04
20385542011016AgaMatrixAgaMatrix, Inc.8000-020132016-11-04
00840423500691VivaGuard Ino Control SolutionABOUND Diagnostics, Inc.VGC01-3732025-06-06
00193169642003TruePointOK BIOTECH CO., LTD.642002025-06-05
00850065253213LIVE TULA Blood Glucose Control Solution W2TULA HEALTH, INC.4908A2024-12-06
14719869705850Tyson Bio HS100 Control Solution (Level 1)TYSON BIORESEARCH INC.HS1002024-12-04
14719869705867Tyson Bio HS100 Control Solution (Level 2)TYSON BIORESEARCH INC.HS1002024-12-04
14719869705874Tyson Bio HS100 Control Solution (Level 3)TYSON BIORESEARCH INC.HS1002024-12-04
00301937109010CONTOUR®ASCENSIA DIABETES CARE US INC.7109B2016-09-16
50301937110011CONTOUR®ASCENSIA DIABETES CARE US INC.7110B2016-09-16
50301937111018CONTOUR®ASCENSIA DIABETES CARE US INC.7111B2016-09-16
50301937314013CONTOUR® NEXTASCENSIA DIABETES CARE US INC.73142016-09-16
10850027494309Easy Talk/PlusII Control Solution LOWHOME AIDE DIAGNOSTICS, INC.ET-PIICTR2024-06-14
10850027494316Easy Talk/PlusII Control Solution HIGHHOME AIDE DIAGNOSTICS, INC.ET-PIICTR2024-06-14
00021292015060TRUENESSTRIVIDIA HEALTH, INC.TRUENESS Control Solution2024-04-03
00021292015077TRUENESSTRIVIDIA HEALTH, INC.TRUENESS Control Solution2024-04-03
00883489002501SMARTMETERBIONIME CORPORATIONGC5502023-12-15
00810008210994ONE-CAREMediVena, LLCAC500 2023-09-10
00816042014383FORAFORA CARE INC.Control Solution_Normal (FORA/gojji)2023-07-07
00816042011993FORAFORA CARE INC.Control Solution (Normal)2023-06-27
00816042012006FORAFORA CARE INC.Control Solution (Normal)2023-06-27
00898939002048FORAFORA CARE INC.Control Solution (High)2023-06-27
00898939002055FORAFORA CARE INC.Control Solution (Low)2023-06-27
00898939002062FORAFORA CARE INC.Control Solution (Normal)2023-06-27
00898939002406FORAFORA CARE INC.Control Solution (Low)2023-06-27
00898939002413FORAFORA CARE INC.Control Solution (Normal)2023-06-27
00898939002420FORAFORA CARE INC.Control Solution (High)2023-06-27
00850031608702GlucertainCELLERA LLC301852023-03-28
00385480631648Nova PrimaryNOVA BIOMEDICAL CORPORATIONNova Primary Ampuled Control 1, 22023-02-24
00385480631655Nova PrimaryNOVA BIOMEDICAL CORPORATIONNova Primary Linearity Level 1 2023-02-24
00385480631662Nova Primary NOVA BIOMEDICAL CORPORATIONNova Primary Linearity Level 22023-02-24
14719869704167Tyson Bio HT100-B Control Solution Level 3TYSON BIORESEARCH INC.HT100-B2023-02-17
14719869704174Tyson Bio HT100-B Control Solution Level 2TYSON BIORESEARCH INC.HT100-B2023-02-17
14719869704181Tyson Bio HT100-B Control Solution Level 1TYSON BIORESEARCH INC.HT100-B2023-02-17
06971292001447AUVONShenzhen Yuwen E-Commerce Co., Ltd.CS12323012022-10-18
00365702701274EXACTA GLANCERoche Diagnostics Operations, Inc.094099550012022-09-02
00365702701489EXACTA GLANCERoche Diagnostics Operations, Inc.094279370012022-09-02
20353885012687OneTouch Ultra PlusLifeScan Europe GmbH024-2822022-08-31
80353885012641OneTouch Ultra PlusLifeScan Europe GmbH024-2722022-08-31
00605388710055ReliOn™ Confirm/Micro ControlWAL-MART STORES, INC.7100052022-03-07
00021292005702TRUE FOCUSTRIVIDIA HEALTH, INC.TRUE FOCUS Control Solution Level 12021-02-26
00021292005719TRUE FOCUSTRIVIDIA HEALTH, INC.TRUE FOCUS Control Solution Level 22021-02-26
00021292005726TRUE FOCUSTRIVIDIA HEALTH, INC.TRUE FOCUS Control Solution Level 32021-02-26
00021292002091TRUEcontrolTRIVIDIA HEALTH, INC.TRUEcontrol Solution Level 02021-01-29
00021292002107TRUEcontrolTRIVIDIA HEALTH, INC.TRUEcontrol Solution Level 12021-01-29
00021292008376TRUEcontrolTRIVIDIA HEALTH, INC.TRUEcontrol Solution Level 22021-01-29
00365702275102Accutrend Glucose ControlsRoche Diagnostics GmbH52132311602021-01-18
1088501700027725 EasyMax FTS Set EN-ESEPS BIO TECHNOLOGY CORP.EASY MAX2020-12-10
1088501700028425 EasyMax 15 FTS Set EN-ESEPS BIO TECHNOLOGY CORP.EASY MAX 152020-12-10
00021292006235TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 12020-10-21
00021292006242TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 22020-10-21
00021292006259TRUE METRIXTRIVIDIA HEALTH, INC.TRUE METRIX Control Solution Level 32020-10-21
08718734960560Eurotrol GlucoTrol-NG Eurotrol B.V.GlucoTrol-NG Level 22020-10-08
08718734960577Eurotrol GlucoTrol-NG Eurotrol B.V.GlucoTrol-NG Level 32020-10-08
08718734960591Eurotrol GlucoTrol-NG Eurotrol B.V.GlucoTrol-NG Level 42020-10-08
08718734960935Eurotrol GlucoTrol-AQEurotrol B.V.180.013.002 2020-10-08
08718734961406GlucoLinEurotrol B.V.025.000.0052020-10-08
00793150629794Oh’Care Lite Glucose Control SolutionOSANG HEALTHCARE Co., Ltd.IGM-1003A2020-09-24
00894046001585Advocate BMB Control Solutions LowDIABETIC SUPPLY OF SUNCOAST, INC.BMB0032016-08-19
00894046001608Advocate BMB Control Solutions HighDIABETIC SUPPLY OF SUNCOAST, INC.0052016-08-19
00015482500061Assure® Dose High (Level 2) Control SolutionARKRAY USA, INC.5000062019-01-15
10885017000550EasyMax NHCS Set ENEPS BIO TECHNOLOGY CORP.EasyMax2020-06-23
10885017000567EasyMax 15 NHCS Set ENEPS BIO TECHNOLOGY CORP.EM442020-06-23
00850001462402GOJJI GLUCOSE CONTROL SOLN-NORMALGOJJI, INC.v12020-04-20
00885017000584EM 15 Blood Glucose Level 1 and Level 2 Control SolutionEPS BIO TECHNOLOGY CORP.EM442019-07-19
10885017000635EM 15 Blood Glucose Level 2 Control SolutionEPS BIO TECHNOLOGY CORP.EM442019-07-19
00605388780058ReliOn™ Premier Control Solution Level 1WAL-MART STORES, INC.7800052019-08-27
00605388780065ReliOn™ Premier Control Solution Level 2WAL-MART STORES, INC.7800062019-08-27
14719869703146TysonBio AC500 Control Solution (Level 1)TYSON BIORESEARCH INC.AC5002020-04-15