FDA.reportPublic FDA data

VITROS

Primary DI
10758750005185
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8892382
Catalog number
8892382
Device description
VITROS Chemistry Products CRBM Slides
Published
2016-08-10
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
KLTENZYME IMMUNOASSAY, CARBAMAZEPINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLTEnzyme Immunoassay, CarbamazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750005185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000518510758750005185

GMDN Terms#

Term, Definition table
TermDefinition
Carbamazepine therapeutic drug monitoring 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 and therapeutic monitoring of the central nervous system drug carbamazepine in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 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
07613336121108ONLINE TDM Carbamazepine Gen.4Roche Diagnostics GmbHKLT2020-03-05
00380740135331AlinityABBOTT LABORATORIESKLT2019-12-09
00630414595986Atellica CH CarbSiemens Healthcare Diagnostics Inc.KLT2017-12-27
05055273206463CBZRANDOX LABORATORIES LIMITEDKLT2016-09-24
00842768000928Syva® Emit® Carbamazepine AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768000935Syva® Emit® Carbamazepine CalibratorsSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768001871Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768001888Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768005770Dimension® Flex® reagent cartridge CRBMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768014352Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768015137Dimension Vista® Flex® reagent cartridge CRBMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768023231Emit® 2000 Carbamazepine AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527130ADVIA Centaur® CARBSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527147ADVIA Centaur® CARB +ZSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527178ADVIA Centaur® CARB MCMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414560793ADVIA® Chemistry CARB_2 ReagentsSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414961095IMMULITE® 2000 Systems CMP CarbamazepineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLT2016-09-24
00630414963679IMMULITE® / IMMULITE® 1000 Systems CMP CarbamazepineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLT2016-09-24
04015630936885ONLINE TDM Carbamazepine Gen4Roche Diagnostics GmbHKLT2016-09-20
04015630999033CarbamazepineRoche Diagnostics GmbHKLT2016-09-20
00884883001251CEDIA Carbamazepine II AssayMicrogenics CorporationKLT2016-09-12
00380740001834ARCHITECTAbbott GmbHKLT2016-09-09
00380740081072ARCHITECTAbbott GmbHKLT2016-09-09
00380740081935ARCHITECTAbbott GmbHKLT2016-09-09
15099590232184SynchronBeckman Coulter, Inc.KLT2016-08-24
00380740102685ARCHITECTABBOTT LABORATORIESKLT2016-06-06