FDA.reportPublic FDA data

VITROS

Primary DI
10758750031658
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6844471
Catalog number
6844471
Device description
VITROS Chemistry Products Cl- Slides
Published
2023-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20758750031655PackageGS130In Commercial Distribution
10758750031658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003165520758750031655
1075875003165810758750031658

GMDN Terms#

Term, Definition table
TermDefinition
Chloride (Cl-) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of chloride (Cl-) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
623873044
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

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
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