FDA.reportPublic FDA data

VITROS

Primary DI
10758750004782
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8343386
Catalog number
8343386
Device description
VITROS Chemistry Products DGXN 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
LFMENZYME IMMUNOASSAY, DIGITOXIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFMEnzyme Immunoassay, DigitoxinClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750004782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000478210758750004782

GMDN Terms#

Term, Definition table
TermDefinition
Digoxin 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 cardiovascular drug digoxin 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
00630414961262IMMULITE 2000 Sytems DigitoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFM2020-08-05
00630414963846IMMULITE/IMMULITE 1000 DigitoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFM2020-08-05
00630414598772Atellica IM DgtnSiemens Healthcare Diagnostics Inc.LFM2018-02-06
00630414598789Atellica IM DgtnSiemens Healthcare Diagnostics Inc.LFM2018-02-06
00842768005510Dimension® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00842768033315Dimension Vista® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00630414203935ADVIA Centaur® DGTNSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00630414207414ADVIA Centaur® DGTN +ZSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00884883005648CEDIA Digitoxin AssayMicrogenics CorporationLFM2016-09-12