FDA.reportPublic FDA data

Glucose IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.
GUDID devices
185
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00365702407107ACCU-CHEK AVIVA PLUSRoche Diagnostics Operations, Inc.069082170012016-08-26
00365702408104ACCU-CHEK AVIVA PLUSRoche Diagnostics Operations, Inc.069082680012016-08-26
00365702428102ACCU-CHEK INFORM IIRoche Diagnostics Operations, Inc.059428610012016-08-26
00365702436107ACCU-CHEK AVIVA PLUSRoche Diagnostics Operations, Inc.069083730012016-08-26
00365702438101ACCU-CHEK AVIVA PLUSRoche Diagnostics Operations, Inc.069083490012016-08-26
00365702493100ACCU-CHEK SMART VIEWRoche Diagnostics Operations, Inc.063375460012016-08-26
00365702495104ACCU-CHEK SMART VIEWRoche Diagnostics Operations, Inc.063375620012016-08-26
00365702602106ACCU-CHEK PERFORMARoche Diagnostics Operations, Inc.072997020012016-08-26
00365702703230ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.10439165001 2025-03-20
00365702703254ACCU-CHECK GUIDERoche Diagnostics Operations, Inc.10439238001 2025-03-20
00365702726109Accu-Chek GuideRoche Diagnostics Operations, Inc.080537230012018-03-30
00613647000502FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FS900-102016-09-24
00681131403283RELIONWAL-MART STORES, INC.094099630012022-09-02
00810079240449Teladoc Health, Inc.Teladoc Health, Inc.BG300 - CH2025-10-10
00810113570761Vive PrecisionVIVE HEALTH LLCDMD1082BLU50CT2023-01-02
00810113570778Vive PrecisionVIVE HEALTH LLCDMD1082BLU100CT2023-01-02
00810128750028CareTouchTianjin Empecs Medical Device Co.,LtdCT1002023-01-13
00810128750097CareTouchTianjin Empecs Medical Device Co.,LtdCT502023-01-13
00851683007332YSI IncorporatedYSI INCORPORATED2365C2026-04-28
00857513006209VeraSens Voicei-SENS, Inc.282104-2012016-09-23
00885325000023CareSens Ni-SENS, Inc.164104-2032016-09-23
00885325000054CareSens N (MedPoint Diagnostics)i-SENS, Inc.1551042016-09-23
00885325000610CareSens N Multii-SENS, Inc.164104-2042020-11-10
00885325000764COOLi-SENS, Inc.5200502016-09-23
00885325000818COOL i-SENS, Inc.5200102016-09-23
00885325001242CareSens Ni-SENS, Inc.1641012020-11-10
00885325001419Tempoi-SENS, Inc.3431042021-02-17
00885325001426Tempoi-SENS, Inc.3431052021-02-17
00892896000017Fifty50i-SENS, Inc.1631402016-09-23
00892896000093Fifty50i-SENS, Inc.1636042016-09-23
10885380112997CARDINAL HEALTHCardinal Health 200, LLCBEV-FP-0502016-08-15
10885380113000CARDINAL HEALTHCardinal Health 200, LLCBEV-FP-0752016-08-15
10885380113017CARDINAL HEALTHCardinal Health 200, LLCBEV-FP-1002016-08-15
10885380113024CARDINAL HEALTHCardinal Health 200, LLCBEV-LL-0502016-08-15
10885380113031CARDINAL HEALTHCardinal Health 200, LLCBEV-LL-0752016-08-15
10885380113048CARDINAL HEALTHCardinal Health 200, LLCBEV-LL-1002016-08-15
10885380113055CARDINAL HEALTHCardinal Health 200, LLCBEV-O-0502016-08-15
10885380113062CARDINAL HEALTHCardinal Health 200, LLCBEV-O-0752016-08-15
10885380113079CARDINAL HEALTHCardinal Health 200, LLCBEV-O-1002016-08-15
00810079240562Teladoc Health, Inc.Teladoc Health, Inc.BG5002026-02-17
00810079240432Teladoc Health, Inc.Teladoc Health, Inc.BG300 - MX2025-09-25
00365702703209 ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.10436271001 2025-03-20
10365702703237ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.10439165001 2025-03-20
10365702703251ACCU-CHECK GUIDERoche Diagnostics Operations, Inc.10439238001 2025-03-20
10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsTECO DIAGNOSTICSGlucopad Blood Glucose Test Strips2024-12-19
06958590303329GoChek2Microtech Medical (Hangzhou) Co., Ltd.1017U+2024-10-08
06958590308850GoChek2Microtech Medical (Hangzhou) Co., Ltd.10262024-10-08
06958590308867GoChek2Microtech Medical (Hangzhou) Co., Ltd.10262024-10-08
20885380113007CARDINAL HEALTHCardinal Health 200, LLCBEV-FP-0752016-08-15
20885380113014CARDINAL HEALTHCardinal Health 200, LLCBEV-FP-1002016-08-15
20885380113021CARDINAL HEALTHCardinal Health 200, LLCBEV-LL-0502016-08-15
20885380113038CARDINAL HEALTHCardinal Health 200, LLCBEV-LL-0752016-08-15
20885380113052CARDINAL HEALTHCardinal Health 200, LLCBEV-O-0502016-08-15
20885380113069CARDINAL HEALTHCardinal Health 200, LLCBEV-O-0752016-08-15
50885380112995CARDINAL HEALTHCardinal Health 200, LLCBEV-FP-0502016-08-15
50885380113046CARDINAL HEALTHCardinal Health 200, LLCBEV-LL-1002016-08-15
50885380113077CARDINAL HEALTHCardinal Health 200, LLCBEV-O-1002016-08-15
10673486001785Teco Diagnostics Glucose (Oxidase) Liquid Reagent SetTECO DIAGNOSTICSG520-1002023-11-30
10673486001778Teco Diagnostics Glucose (Oxidase) Liquid Reagent SetTECO DIAGNOSTICSG520-1L2023-11-21
10673486001693Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSG518-1502023-11-10
10673486001709Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSG518-4002023-11-10
10673486001716Teco Diagnostics Glucose (Oxidase) Reagent SetTECO DIAGNOSTICSG519-2502023-11-10
10673486001723Teco Diagnostics Glucose (Oxidase) Reagent SetTECO DIAGNOSTICSG519-1L2023-11-10
10673486001754Teco Diagnostics Glucose (Oxidase) Liquid Reagent SetTECO DIAGNOSTICSG520-4802023-11-10
10673486001761Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC MatrixTECO DIAGNOSTICSG520-940TM2023-11-10
10673486001662Teco Diagnostics Glucose (Hexokinase) Liquid ReagentTECO DIAGNOSTICSG516-1502023-11-09
10673486001686Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-MatrixTECO DIAGNOSTICSG516-870TM2023-11-09
10758750004812VITROSORTHO-CLINICAL DIAGNOSTICS, INC.83790342016-08-26
10758750009572VITROSORTHO-CLINICAL DIAGNOSTICS, INC.17078012016-08-10
00853553005738Livongo Test Strips - MexicoLIVONGO HEALTH, INCLivongo2022-09-20
00681131403276RELIONWAL-MART STORES, INC.094099710012022-09-02
50681131403288RELIONWAL-MART STORES, INC.094099630012022-09-02
00860008115911TenoviTenovi Co.TE-STR-A12022-01-17
06958590303046Gochek2Microtech Medical (Hangzhou) Co., Ltd.10262021-11-12
10885325001416Tempoi-SENS, Inc.3431042021-02-17
10885325001423Tempoi-SENS, Inc.3431052021-02-17
00860005561704ScanLEXINGTON WELLNESS HOLDINGS INC.G-427BS2021-02-01
20859047006001Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATED10-FP-0502018-12-31
20859047006018Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATED10-FP-0752018-12-31
20859047006025Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATED10-FP-1002018-12-31