FDA.reportPublic FDA data

Glucose IVD, kit, spectrophotometry

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.
GUDID devices
44
Last updated
2026-07-17 21:59:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628063400515GLUCOSE-SL AssaySekisui Diagnostics, LLC235-602016-09-16
00628063400522GLUCOSE-SLSekisui Diagnostics, LLC235-992016-09-20
00628063400539GLUCOSESekisui Diagnostics, LLCSK235-102016-09-20
00075537490709ACCU-CHEK COMPACT PLUS Roche Diagnostics Operations, Inc.031491370012016-08-26
00194346193264RELIONWAL-MART STORES, INC.101898510012025-01-17
00365702192102ACCU-CHEK COMPACT PLUS Roche Diagnostics Operations, Inc.059076750012016-08-26
00365702220102ACCU-CHEK COMPACT PLUSRoche Diagnostics Operations, Inc.051772940012016-08-26
00365702482104ACCU-CHEK NANO Roche Diagnostics Operations, Inc.063335830012016-08-26
00365702483101ACCU-CHEK NANO Roche Diagnostics Operations, Inc.063338850012016-08-26
00365702576100ACCU-CHEK AVIVA CONNECT Roche Diagnostics Operations, Inc.070496920012016-08-26
00365702577107ACCU-CHEK AVIVA CONNECT Roche Diagnostics Operations, Inc.070497060012016-08-26
00365702578104ACCU-CHEK AVIVA CONNECT Roche Diagnostics Operations, Inc.070498110012016-08-26
00365702702035ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.074008700012017-02-02
00365702702295Accu-Chek Guide LinkRoche Diagnostics Operations, Inc.081160830222020-10-30
00365702702479ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.096519260012023-09-06
00365702702530ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.09651942001 2023-09-06
00365702702882ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.099783300012023-09-21
00365702703216ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.10439050001 2025-03-20
00365702724105Accu-Chek Aviva Roche Diagnostics Operations, Inc.083500600012018-03-01
00365702728103Accu-Chek GuideRoche Diagnostics Operations, Inc.084530630012018-06-01
00365702730106ACCU-CHEK GUIDE MERoche Diagnostics Operations, Inc.084998880012019-08-27
00365702732100Accu-Chek Guide MeRoche Diagnostics Operations, Inc.084999000012019-04-08
00365702733107Accu-Chek Guide MeRoche Diagnostics Operations, Inc.084999180012019-04-08
00365702738102Accu-Chek Guide LinkRoche Diagnostics Operations, Inc.090157280012020-10-30
00630414654126Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.116457622026-03-18
05204309039791GlucoseMEDICON HELLAS S.A.1418-00172026-04-27
05204309123421GlucoseMEDICON HELLAS S.A.1419-00182026-04-27
03701700800156ENVOY 500 GLUCOSE REAGENT KITVITALSCIENTIFIC553452025-03-31
03701700820505GLUCOSE PAP SLVITALSCIENTIFICGPSL-02502025-03-31
10365702703213ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.10439050001 2025-03-20
10365702702889ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.099783300012023-09-21
10365702702476ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.096519260012023-09-06
10365702702537ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.09651942001 2023-09-06
00811727015846Pointe Glucose Hexokinase for BS480HORIBA INSTRUMENTS INCORPORATED14-G7517-4802020-05-28
03610230005200ABX PENTRA GLUCOSE HK CPHORIBA ABX SAS12200016672016-08-23
03610230005217ABX PENTRA GLUCOSE PAP CPHORIBA ABX SAS12200016682016-08-23
03661540202100ENVOY 500 GLUCOSE REAGENT KITVITALSCIENTIFIC553452016-09-24
03661540214608GLUCOSE PAP SLVITALSCIENTIFICGPSL-02502016-09-24
04015630911738Glucoquant GlucoseHKRoche Diagnostics GmbH119295342162016-09-20
04015630911745Glucoquant GlucoseHKRoche Diagnostics GmbH119295422162016-09-20
04015630920297Glucose HKRoche Diagnostics GmbH44044831902016-09-20
04015630922338Glucose HKRoche Diagnostics GmbH46575271902016-09-20
04015630925025Glucose HK Gen3Roche Diagnostics GmbH51687911902016-09-20
04015630991853Glucoquant GlucoseHKRoche Diagnostics GmbH118768992162016-09-20