JGS

Product Code: JGS


Products Classified as JGS

403Electrode, Ion Specific, SodiumSodium Test System.

Total Product Life Cycle (TPLC) Devices

403Electrode, Ion Specific, SodiumSodium Test System.

FDA Consensus Standards

Electrode, Ion Specific, Sodium [11427]21 CFR §862.1665 🔎

Pre-market Notifications for JGS

K213486GLP Systems TrackAbbott Laboratories
K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation
K191365Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation
K183688I-STAT CHEM8+ Cartridge With The I-STAT 1 SystemAbbott Point Of Care, Inc.
K183549GEM Premier ChemSTATInstrumentation Laboratory Co.
K181201Synermed ISE ReagentsInfrared Laboratory Systems, LLC (dba Synermed)
K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation
K172232LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine Reagent, LIASYS 600AMS Diagnostics
K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.
K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics
K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBECKMAN COULTER INC.
K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 TBili, GEM System Evaluator, GEM Hematocrit EvaluatorINSTRUMENTATION LABORATORY CO.
K153357I-STAT Alinity System With I-STAT Sodium TestABBOTT POINT OF CARE INC.
K151767Trinidad CH System, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP Reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSIEMENS HEALTHCARE DIAGNOSTICS, INC.

Global Unique Device Identification Database

00386100002978Electrode, Ion Specific, Sodium
00386100002831Electrode, Ion Specific, Sodium
00386100002817Electrode, Ion Specific, Sodium
00386100002794Electrode, Ion Specific, Sodium
00386100002541Electrode, Ion Specific, Sodium
00386100002503Electrode, Ion Specific, Sodium
00386100002459Electrode, Ion Specific, Sodium
00386100001650Electrode, Ion Specific, Sodium
00386100001636Electrode, Ion Specific, Sodium
00385480536660ELECTRODE, ION SPECIFIC, SODIUM
00385480492058ELECTRODE, ION SPECIFIC, SODIUM
00385480485937ELECTRODE, ION SPECIFIC, SODIUM
00385480485791ELECTRODE, ION SPECIFIC, SODIUM
00385480485678ELECTRODE, ION SPECIFIC, SODIUM
00385480485586ELECTRODE, ION SPECIFIC, SODIUM

Maude Adverse Events

I-STAT E3+ CARTRIDGEABBOTT POINT OF CARE2020-03-31
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-03-18
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-03-18
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-02-13
ISE INDIRECT NA+ FOR GEN.2ROCHE DIAGNOSTICS2020-02-11
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-02-05
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-03
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2020-01-31
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2020-01-31
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2020-01-31
I-STAT E3+ CARTRIDGEABBOTT POINT OF CARE2020-01-29
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-01-29
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-01-29
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-01-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-01-15
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-01-15
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2020-01-08
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-11-26
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-11-19
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-11-13
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-11-06
BS-2000M CHEMISTRY ANALYZERSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2019-11-04
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-10-24
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-10-24
I-STAT E3+ CARTRIDGEABBOTT POINT OF CARE2019-10-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-10-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-10-17
ISE SODIUM ELECTRODEROCHE DIAGNOSTICS2019-10-15
I-STAT EC4+ CARTRIDGEABBOTT POINT OF CARE2019-10-09
I-STAT EC4+ CARTRIDGEABBOTT POINT OF CARE2019-10-09
I-STAT EC4+ CARTRIDGEABBOTT POINT OF CARE2019-10-09
I-STAT EC4+ CARTRIDGEABBOTT POINT OF CARE2019-10-09
I-STAT EC4+ CARTRIDGEABBOTT POINT OF CARE2019-10-09
ISE INDIRECT NA, K, CI FOR GEN.2ROCHE DIAGNOSTICS2019-10-04
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP.2019-09-25
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-09-20
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-18
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-18
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-17
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-17
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-09-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-09-17
I-STAT E3+ CARTRIDGEABBOTT POINT OF CARE2019-09-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-09-17
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP.2019-08-28
VITROS CHEMISTRY PRODUCTS NA+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-08-21
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-07-30
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2019-07-30
I-STAT EC4+ CARTRIDGEABBOTT POINT OF CARE2019-07-30
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