FDA.reportPublic FDA data

ISE Chloride Electrode

Primary DI
00657498001899
Brand
ISE Chloride Electrode
Company
STANBIO LABORATORY, L.P.
Model
20270475
Catalog number
20270475
Device description
Ion-Selective Electrode for the measurement of chloride in serum.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00657498001899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001899006574980018996574980018990657498001899

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESCGZ2025-10-08
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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
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807612GEM Premier 5000 PAK BG/ISE/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807636GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807643GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807674GEM Premier 5000 PAK BG/ISE/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807681GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807698GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807704GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24