FDA.reportPublic FDA data

VITROS

Primary DI
10758750004270
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8046872
Catalog number
8046872
Device description
VITROS Chemistry Products ALC Slides
Published
2016-08-23
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
DMTENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, ULTRAVIOLET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMTEnzymatic Method, Alcohol Dehydrogenase, UltravioletClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750004270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000427010758750004270

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) 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 ethyl alcohol (ETOH) 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
06942284613443femometerJOYTECH HEALTHCARE CO.,LTDDMT2026-05-25
00380740135393AlinityABBOTT LABORATORIESDMT2019-04-16
00380740135386AlinityABBOTT LABORATORIESDMT2018-07-11
00884883012486DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-22
00884883001008DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00884883002890DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00817302021851CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421CAROLINA LIQUID CHEMISTRIES CORPORATIONDMT2016-09-01
15099590223335SynchronBeckman Coulter, Inc.DMT2016-08-24
00380740005559ARCHITECTABBOTT LABORATORIESDMT2016-06-06