FDA.reportPublic FDA data

Glucose IVD, kit, enzyme spectrophotometry

Definition
A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.
GUDID devices
84
Last updated
2022-11-28 17:54:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613336161791Glucose HK Gen. 3 Roche Diagnostics GmbH051687912142022-11-18
00365702701212RELIONWAL-MART STORES, INC.093970510012022-09-02
00681131403399RELIONWAL-MART STORES, INC.095567290012022-09-02
03661540200168EON 100 GLUCOSE REAGENTVITALSCIENTIFIC773452016-09-24
03661540200533EON 300 GLUCOSE REAGENTVITALSCIENTIFIC793452016-09-24
00811727016157Pointe Glucose ReagentHORIBA INSTRUMENTS INCORPORATED16-G7517-5282021-01-30
00365702702134Accu-Chek Guide LinkRoche Diagnostics Operations, Inc.081092570012020-10-30
10365702702292Accu-Chek Guide LinkRoche Diagnostics Operations, Inc.081160830222020-10-30
10365702738109Accu-Chek Guide LinkRoche Diagnostics Operations, Inc.090157280012020-10-30
03610230007013Yumizen C1200 Glucose HKHORIBA ABX SAS13000238482020-05-06
03610230007020Yumizen C1200 Glucose HKHORIBA ABX SAS13000238492020-05-06
07613336121283Glucose HKRoche Diagnostics GmbH080578001902020-03-05
00380740161583ARCHITECTAbbott GmbH3L82-222020-01-04
00380740161590ARCHITECTAbbott GmbH3L82-422020-01-04
10365702730103ACCU-CHEK GUIDE MERoche Diagnostics Operations, Inc.084998880012019-08-27
00365702702042ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.074009260012017-02-02
10365702702032ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.074008700012017-02-02
00365702731103Accu-Chek Guide MeRoche Diagnostics Operations, Inc.084998960012019-04-08
10365702732107Accu-Chek Guide MeRoche Diagnostics Operations, Inc.084999000012019-04-08
10365702733104Accu-Chek Guide MeRoche Diagnostics Operations, Inc.084999180012019-04-08
15099590010195AUBeckman Coulter, Inc.OSR61212016-09-24
15099590020101AUBeckman Coulter, Inc.OSR62212016-09-24
15099590060084AUBeckman Coulter, Inc.OSR66212016-09-24
15099590193072SynchronBeckman Coulter, Inc.B249852016-08-24
16438153817793Glucose (HK)Thermo Fisher Scientific OyNONE2016-08-30
00842768005541Dimension® Flex® reagent cartridge GLUCSiemens Healthcare Diagnostics Inc.104449712016-09-24
00842768015663Dimension Vista® Flex® reagent cartridge GLUSiemens Healthcare Diagnostics Inc.104451622016-09-24
00851445007211GENCHEM™ Glucose Oxidase ReagentGENCHEM INCGEN-GLU32016-09-19
00851445007228GENCHEM™ Glucose Oxidase ReagentGENCHEM INCGEN-GLU LX2016-09-19
00851445007235GENCHEM™ Glucose ReagentGENCHEM INCGEN-GLU42016-09-19
10075537490706ACCU-CHEK COMPACT PLUS Roche Diagnostics Operations, Inc.031491370012016-08-26
00817302020618CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 GLU RGT KIT Product No. ST208CAROLINA LIQUID CHEMISTRIES CORPORATIONST2082016-09-01
00817302020625CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT BL-208CAROLINA LIQUID CHEMISTRIES CORPORATIONBL2082016-09-01
00817302020632CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT AU-208CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-2082016-09-01
00817302020649CAROLINA LIQUID CHEMISTRIES CORP.® GLU GLUCOSE REAGENT CC208CAROLINA LIQUID CHEMISTRIES CORPORATIONCC2082016-09-01
00817302020656CAROLINA LIQUID CHEMISTRIES CORP.® GLUCOSE REAGENT 88807CAROLINA LIQUID CHEMISTRIES CORPORATION888072016-09-01
00817302022995CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208CAROLINA LIQUID CHEMISTRIES CORPORATIONDT2082016-10-17
00811727011169Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDG7517-1202016-08-31
00811727011176Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDG7517-5002016-08-31
00811727011183Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDG7517-1L2016-08-31
00811727011268Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDG7521-1202016-08-31
00811727011275Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDG7521-5002016-08-31
00811727011282Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDG7521-1L2016-08-31
00811727012692Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHG921-10002016-08-31
00811727013033Pointe Scientific, Inc. Glucose OxidaseHORIBA INSTRUMENTS INCORPORATEDHG921-8042016-08-31
00811727015020Pointe Scientific, Inc. GlucoseHORIBA INSTRUMENTS INCORPORATEDOG917-3962016-08-31
00657498000809Glucose Liqui-UV®STANBIO LABORATORY, L.P.1060-5002016-09-23
00657498000816Glucose LiquiColor®STANBIO LABORATORY, L.P.1070-1252016-09-23
00657498000823Glucose LiquiColor®STANBIO LABORATORY, L.P.1070-5002016-09-23
00657498000830Glucose LiquiColor®STANBIO LABORATORY, L.P.1071-0012016-09-23
00657498001615Sirrus® Glucose Liqui-UV®STANBIO LABORATORY, L.P.S1060-6002016-09-23
00630414526720ADVIA® Chemistry GLUO_c Glucose Oxidase Reagents, ConcentratedSiemens Healthcare Diagnostics Inc.103358722016-09-24
00630414526812ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 ReagentsSiemens Healthcare Diagnostics Inc.103358912016-09-24
00630414561899ADVIA® Chemistry GLUH_c Glucose Hexokinase_3 Reagents, ConcentratedSiemens Healthcare Diagnostics Inc.103775022016-09-24
00630414578941ADVIA® Chemistry GLUO Glucose Oxidase ReagentsSiemens Healthcare Diagnostics Inc.104923192016-09-24
00630414595634Atellica CH GluOSiemens Healthcare Diagnostics Inc.110976212017-12-21
00630414596488Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.110975922017-12-22
00365702101104ACCU-CHEK AVIVA PLUS Roche Diagnostics Operations, Inc.069885800012016-08-26
00365702102101ACCU-CHEK AVIVA PLUS Roche Diagnostics Operations, Inc.069886010012016-08-26
00365702134102ACCU-CHEK AVIVA PLUS Roche Diagnostics Operations, Inc.070219410012016-08-26
10365702192109ACCU-CHEK COMPACT PLUS Roche Diagnostics Operations, Inc.059076750012016-08-26
10365702220109ACCU-CHEK COMPACT PLUSRoche Diagnostics Operations, Inc.051772940012016-08-26
00365702445109ACCU-CHEK AVIVA PLUS Roche Diagnostics Operations, Inc.069885630012016-08-26
00365702457102ACCU-CHEK PERFORMA Roche Diagnostics Operations, Inc.059595510012016-08-26
00365702486102ACCU-CHEK NANO Roche Diagnostics Operations, Inc.063338340012016-08-26
00365702567108ACCU-CHEK NANO Roche Diagnostics Operations, Inc.070083250012016-08-26
00365702575103ACCU-CHEK AVIVA EXPERT Roche Diagnostics Operations, Inc.066994300012016-08-26
00365702580107ACCU-CHEK AVIVA EXPERT Roche Diagnostics Operations, Inc.071627580012016-08-26
00365702594104ACCU-CHEK AVIVA EXPERTRoche Diagnostics Operations, Inc.071894860012016-08-26
00365702595101ACCU-CHEK AVIVA EXPERT Roche Diagnostics Operations, Inc.071894940012016-08-08
10365702482101ACCU-CHEK NANO Roche Diagnostics Operations, Inc.063335830012016-08-26
10365702483108ACCU-CHEK NANO Roche Diagnostics Operations, Inc.063338850012016-08-26
10365702576107ACCU-CHEK AVIVA CONNECT Roche Diagnostics Operations, Inc.070496920012016-08-26
10365702577104ACCU-CHEK AVIVA CONNECT Roche Diagnostics Operations, Inc.070497060012016-08-26
10365702578101ACCU-CHEK AVIVA CONNECT Roche Diagnostics Operations, Inc.070498110012016-08-26
00365702723108Accu-Chek AvivaRoche Diagnostics Operations, Inc.083500510012018-03-01
00365702725102Accu-Chek Aviva Roche Diagnostics Operations, Inc.083500780012018-03-01
10365702724102Accu-Chek Aviva Roche Diagnostics Operations, Inc.083500600012018-03-01
10365702728100Accu-Chek GuideRoche Diagnostics Operations, Inc.084530630012018-06-01
00365702729100Accu-Chek GuideRoche Diagnostics Operations, Inc.084530710012018-03-02