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
249
Last updated
2026-09-04 23:10:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00859519002056BioTel Care® Double Control SolutionTELCARE, LLCCS2019-03-11
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.BG 1502026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.BG 1502026-08-19
00015482500054Assure® Dose Normal (Level 1) Control SolutionArkray USA, Inc.5000052019-01-15
00015482500061Assure® Dose Normal/High Control SolutionArkray USA, Inc.5000062019-01-15
00015482502041Assure® Dose Normal (Level 1) Control SolutionArkray USA, Inc.5020042020-02-28
00015482502058Assure® Dose Normal (Level 1) Control SolutionArkray USA, Inc.5020052020-02-28
00015482510046Assure® Control - Control Solution Level 1Arkray USA, Inc.5100042019-04-01
00015482510053Assure® Control - Control Solution Level 2Arkray USA, Inc.5100052019-04-01
00015482510060Assure® Control - Control Solution Level 2 & Level 3Arkray USA, Inc.5100062025-09-26
00015482510077Assure® Control - Control Solution Level 3Arkray USA, Inc.5100072019-04-01
00015482530068Assure® Prism Control SolutionArkray USA, Inc.5300062019-01-22
00015482540050GLUCOCARD® Shine Level 1 Control SolutionArkray 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
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.OGS-2112026-07-30
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.Tyson Bio AC500 PRO2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.Tyson Bio AC500 PRO2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.Tyson Bio AC500 PRO2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.BG 1502026-07-13
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
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