FDA.reportPublic FDA data

Chloride Electrode

Primary DI
04987762129858
Brand
Chloride Electrode
Company
JEOL LTD.
Model
781611393
Published
2020-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CGZElectrode, Ion-Specific, Chloride

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987762129858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987762129858049877621298584987762129858

GMDN Terms#

Term, Definition table
TermDefinition
Chloride (Cl-) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of chloride (Cl-) ions in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690565023
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987762129759ISE Buffer (IS)7816113342020-10-09
04987762129766Reagent Probe Wash S7816114822020-09-15
04987762129773Reagent Probe Wash K7816114742020-09-15
04987762129780Reagent Probe Wash 27816114662020-09-15
04987762129797Reagent Probe Wash 17816114582020-09-15
04987762129810Cuvette Conditioner EX7816114312020-09-15
04987762129827Cuvette Wash Solution 77816114232020-09-15
04987762129834ISE Detergent Solution7816114152020-09-15
04987762129889ISE Serum Standard Set NA7816113512020-09-15
04987762129896Internal Standard7816113422020-09-15
04987762129902ISE Urine Standard Set7816113692020-09-15
04987762129803Lamp Coolant C7816114402020-09-15
04987762129841Reference Electrode7816114072020-09-15
04987762129865Potassium Electrode7816113852020-09-15
04987762129872Sodium Electrode7816113772020-09-15

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Primary DI, Brand, Company table
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05700699446572SP90Radiometer Medical ApSCGZ2026-07-09
05700699447579SP90Radiometer Medical ApSCGZ2026-07-09
05700699461056SC90Radiometer Medical ApSCGZ2026-07-09
05700699461087SC90Radiometer Medical ApSCGZ2026-07-09
05700699461094SC90Radiometer Medical ApSCGZ2026-07-09
05700699461100SC90Radiometer Medical ApSCGZ2026-07-09
05700699461605SC90Radiometer Medical ApSCGZ2026-07-09
00380740215712AlinityABBOTT LABORATORIESCGZ2025-10-08
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
00385480616218Stat ProfileNOVA BIOMEDICAL CORPORATIONCGZ2022-12-07
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CGZ2020-04-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCGZ2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCGZ2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCGZ2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCGZ2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCGZ2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCGZ2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCGZ2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCGZ2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCGZ2018-12-11
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCGZ2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCGZ2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCGZ2018-12-04
00380740121686AlinityAbbott GmbHCGZ2018-05-30
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24