FDA.reportPublic FDA data

Chloride Electrode

Primary DI
00386100002473
Brand
Chloride Electrode
Company
MEDICA CORPORATION
Model
4203
Catalog number
4203
Device description
Chloride Electrode for use with EasyElectrolyte Analyzers
Published
2018-12-11
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000926000EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERMedica Corp.2000-05-15CGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100002473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100002473003861000024733861000024730386100002473

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 Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-275-4892technicalsupport@medicacorp.com

Regulatory Flags#

DUNS number
112942404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386100002145ALB Reagent Kit10218-410218-42019-02-14
00386100002008CHOL Reagent Kit 10204-410204-42019-02-14
00386100002022SGOT (AST) Reagent Kit10206-410206-42019-02-14
00386100002039TBIL Reagent Kit10207-410207-42019-02-14
00386100002053CO2 Reagent Kit 10209-410209-42019-02-14
00386100002060Ca Reagent Kit 10210-410210-42019-02-14
00386100002077HDL CHOL Reagent Kit10211-410211-42019-02-14
00386100002084DBIL Reagent Kit 10212-410212-42019-02-14
00386100002107ALP Reagent Kit 10214-410214-42019-02-14
00386100002121TRIG Reagent Kit10216-410216-42019-02-14
00386100002138AMY Reagent Kit10217-410217-42019-02-14
00386100002169Mg Reagent Kit10220-410220-42019-02-14
00386100002176Phos Reagent Kit10221-410221-42019-02-14
00386100002183CK Reagent Kit 10222-410222-42019-02-14
00386100002190Iron (Fe) Reagent Kit10223-410223-42019-02-14
00386100002206LDL CHOL Reagent Kit 10224-410224-42019-02-14
00386100002213UALB Reagent Kit10225-410225-42019-02-14
00386100002237Lipase Reagent Kit 10227-410227-42019-02-20
00386100002244CRP Reagent Kit10228-410228-42019-02-14
00386100002268HbA1c Reagent Kit 10230-210230-22019-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693930978ABL90 FLEXRadiometer Medical ApSCGZ2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
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