CGL

Product Code: CGL


Products Classified as CGL

300Electrode, Ion Based, Enzymatic, CreatinineCreatinine Test System.

Total Product Life Cycle (TPLC) Devices

300Electrode, Ion Based, Enzymatic, CreatinineCreatinine Test System.

FDA Consensus Standards

Electrode, Ion Based, Enzymatic, Creatinine [32368]21 CFR §862.1225 🔎

Pre-market Notifications for CGL

K171059Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation
K113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTEPOCAL, INC.
K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNOVA BIOMEDICAL CORP.
K051968ABL8X7 FLEXRADIOMETER MEDICAL APS
K991727STAT PROFILE M7 ANALYZERNOVA BIOMEDICAL CORP.
K973292I-STAT SYSTEMI-STAT CORP.
K903034RENALYZER PRX 90SWEDISH TRADE COUNCIL USA

Global Unique Device Identification Database

10385480560365ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480534397ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480534007ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480519967ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480506684ELECTRODE, ION BASED, ENZYMATIC, CREATININE
00385480485975ELECTRODE, ION BASED, ENZYMATIC, CREATININE
00385480485951ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480453353ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480440520ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480438060ELECTRODE, ION BASED, ENZYMATIC, CREATININE
10385480282410ELECTRODE, ION BASED, ENZYMATIC, CREATININE
00385480173605ELECTRODE, ION BASED, ENZYMATIC, CREATININE
00385480131421ELECTRODE, ION BASED, ENZYMATIC, CREATININE
05700699456632ELECTRODE, ION BASED, ENZYMATIC, CREATININE
05700699456625ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Maude Adverse Events

EPOC HOST 2 MOTOROLAEPOCAL INC.2020-03-12
EPOC HOSTEPOCAL INC.2020-02-27
EPOC READEREPOCAL INC.2020-02-21
EPOC READEREPOCAL INC.2020-02-12
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-11-26
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-19
EPOC HOST 2 JAPANEPOCAL INC.2019-11-11
EPOC READEREPOCAL INC.2019-10-29
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-10-24
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-08-21
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-08-21
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEMNOVA BIOMEDICAL CORP.2019-07-18
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-07-03
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-06-05
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-05-16
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2019-05-07
NOVA STAT PROFILE PHOX ULTRANOVA BIOMEDICAL CORPORATION2019-01-11
NOVA STAT PROFILE PHOX ULTRANOVA BIOMEDICAL CORPORATION2019-01-11
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEMNOVA BIOMEDICAL CORPORATION2018-12-11
EPOC BLOOD ANALYSIS SYSTEMEPOCAL INC2018-11-30
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEMNOVA BIOMEDICAL CORPORATION2018-10-30
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-10-24
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-09-13
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-09-06
NOVA STAT PROFILE CRITICAL CARE XPRESSNOVA BIOMEDICAL CORPORATION2018-07-17
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-04-26
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-04-26
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-03-30
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2018-03-08
EPOC BLOOD ANALYSIS SYSTEMEPOCAL INC.2017-12-01
CARE-FILL CAPILLARY TUBESEPOCAL, INC.2017-10-17
CARE-FILL CAPILLARY TUBESEPOCAL, INC.2017-10-17
CARE-FILL CAPILLARY TUBESEPOCAL, INC.2017-10-17
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-10-11
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-10-10
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-10-10
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-10-10
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-10-07
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-09-11
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-09-11
I-STAT CREA CARTRIDGEABBOTT POINT OF CARE2017-07-10

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