FDA.reportPublic FDA data

CL ELECTRODE, ISE MODULE

Primary DI
15999883586706
Brand
CL ELECTRODE, ISE MODULE
Company
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Resz
Model
Cl- Electrode
Catalog number
5203
Device description
Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K101741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101741000DIATRON PICTUS 400Diatron Group2011-01-25CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15999883586706PackageGS11In Commercial Distribution
05999883586709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1599988358670615999883586706
05999883586709059998835867095999883586709

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth40Millimeter
Height60Millimeter
Width90Millimeter

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
+1207-450-4228John.Roche@diatron.com

Regulatory Flags#

DUNS number
427395277
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15999883586683NA ELECTRODE, ISE MODULENA+ Electrode52012016-10-06

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