Product Code: CGA


Products Classified as CGA

292Glucose Oxidase, GlucoseGlucose Test System.

Total Product Life Cycle (TPLC) Devices

292Glucose Oxidase, GlucoseGlucose Test System.

FDA Consensus Standards

Glucose Oxidase, Glucose [32368]21 CFR §862.1345 🔎
Glucose Oxidase, Glucose [35909]21 CFR §862.1345 🔎
Glucose Oxidase, Glucose [35812]21 CFR §862.1345 🔎

Pre-market Notifications for CGA

K210958I-STAT CHEM8+ Cartridge With The I-STAT 1 SystemAbbott Point Of Care Inc.
K200349Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation
K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.
K183678I-STAT CHEM8+ Cartridge With The I-STAT 1 SystemAbbott Point Of Care, Inc.
K183546GEM Premier ChemSTATInstrumentation Laboratory Co.
K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/b/a PTS Diagnostics
K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation
K163433VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics
K163271I-Stat Alinity System With I-Stat Glucose TestAbbott Point Of Care, Inc.
K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/b/a PTS Diagnostics
K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation
K161818GEM Premier 3000Instrumentation Laboratory Co.
K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate And Total Bilirubin)Instrumentation Laboratory Co.
K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerINFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
K151639ABL80 FLEX And ABL80 FLEX CO-OXSENDX MEDICAL INC

Global Unique Device Identification Database

20605388860174GLUCOSE OXIDASE, GLUCOSE
20605388564478GLUCOSE OXIDASE, GLUCOSE
10605388022940GLUCOSE OXIDASE, GLUCOSE
10385480565100GLUCOSE OXIDASE, GLUCOSE
10385480560372GLUCOSE OXIDASE, GLUCOSE
00385480534208GLUCOSE OXIDASE, GLUCOSE
10385480534021GLUCOSE OXIDASE, GLUCOSE
00385480533997GLUCOSE OXIDASE, GLUCOSE
00385480533980GLUCOSE OXIDASE, GLUCOSE
00385480526173GLUCOSE OXIDASE, GLUCOSE
10385480519950GLUCOSE OXIDASE, GLUCOSE
10385480517567GLUCOSE OXIDASE, GLUCOSE
10385480517079GLUCOSE OXIDASE, GLUCOSE
00385480504362GLUCOSE OXIDASE, GLUCOSE
00385480489546GLUCOSE OXIDASE, GLUCOSE

Maude Adverse Events

CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-20
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-12
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-06
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-06
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-06
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-06
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-04
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-02
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-03-02
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-21
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-21
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-21
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-21
VITROS CHEMISTRY PRODUCTS GLU SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-18
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-13
I-STAT1 ANALYZER, IMMUNO READY, WIRELESSABBOTT POINT OF CARE2020-02-13
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-12
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-12
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-02-07
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-01-31
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-01-31
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-01-31
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-01-31
OT VERIO TEST STRIPLIFESCAN EUROPE GMBH2020-01-31
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-01-16
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2020-01-07
I-STAT1 ANALYZER, IMMUNO READY, WIRELESSABBOTT POINT OF CARE2019-11-19
I-STAT1 ANALYZER, IMMUNO READYABBOTT POINT OF CARE2019-11-06
VITROS CHEMISTRY PRODUCTS GLU SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-16
VITROS CHEMISTRY PRODUCTS GLU SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-16
VITROS CHEMISTRY PRODUCTS GLU SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-16
VITROS CHEMISTRY PRODUCTS GLU SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-16
VITROS CHEMISTRY PRODUCTS GLU SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-07
CARDIOCHEK PA ANALYZERPTS DIAGNOSTICS2019-09-27
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2019-09-27
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2019-09-27
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2019-09-23
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2019-09-23
ACCUTREND ? TEST STRIPSROCHE DIAGNOSTICS2019-09-17
OT SELECT SIMPLE METERLIFESCAN EUROPE GMBH2019-09-11
OT SELECT TEST STRIPSLIFESCAN EUROPE GMBH2019-08-30
OT ULTRA TEST STRIPSLIFESCAN EUROPE GMBH2019-08-26
LDX LIPID PROFILE+GLUCOSE (10T)ALERE SAN DIEGO2019-08-21
I-STAT1 ANALYZER, IMMUNO READYABBOTT POINT OF CARE2019-08-21
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2019-08-14
CARDIOCHEK PLUS ANALYZERPTS DIAGNOSTICS2019-08-14
ACCUTREND ? PLUSROCHE DIAGNOSTICS2019-08-05
ACCUTREND ? PLUSROCHE DIAGNOSTICS2019-08-05
OT FASTTAKE METERLIFESCAN EUROPE GMBH2019-07-30
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