FDA.reportPublic FDA data

VITROS

Primary DI
10758750010233
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8157596
Catalog number
8157596
Device description
VITROS Chemistry Products K+ Slides
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750010233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875001023310758750010233

GMDN Terms#

Term, Definition table
TermDefinition
Potassium (K+) 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 potassium (K+) in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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 ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSCEM2026-07-09
05700699461056SC90Radiometer Medical ApSCEM2026-07-09
05700699461087SC90Radiometer Medical ApSCEM2026-07-09
05700699461094SC90Radiometer Medical ApSCEM2026-07-09
05700699461100SC90Radiometer Medical ApSCEM2026-07-09
05700699461131SC90Radiometer Medical ApSCEM2026-07-09
05700699461605SC90Radiometer Medical ApSCEM2026-07-09
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCEM2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCEM2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCEM2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCEM2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCEM2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCEM2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONCEM2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONCEM2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05