FDA.reportPublic FDA data

VITROS

Primary DI
10758750008339
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
1037274
Catalog number
1037274
Device description
VITROS Chemistry Products ACET 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
LDPCOLORIMETRY, ACETAMINOPHEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDPColorimetry, AcetaminophenClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750008336PackageGS130In Commercial Distribution
10758750008339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000833620758750008336
1075875000833910758750008339

GMDN Terms#

Term, Definition table
TermDefinition
Acetaminophen 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 qualitative and/or quantitative detection of acetaminophen 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
00630414654164Atellica CH Acetaminophen (AcetC)Siemens Healthcare Diagnostics Inc.LDP2025-10-15
00628063401314Alinity c AcetaminophenSEKISUI DIAGNOSTICS, LLCLDP2023-05-08
07613336120934ONLINE TDM Acetaminophen Gen.2Roche Diagnostics GmbHLDP2020-03-05
00628063401185Acetaminophen AssaySEKISUI DIAGNOSTICS, LLCLDP2019-10-02
00628063401215Acetaminophen L3K AssaySEKISUI DIAGNOSTICS, LLCLDP2019-10-02
30014613337867TriageQUIDEL CARDIOVASCULAR INC.LDP2018-11-01
30014613337904TriageQUIDEL CARDIOVASCULAR INC.LDP2018-11-01
00630414595894Atellica CH AcetSiemens Healthcare Diagnostics Inc.LDP2017-12-22
00842768001550Syva® Emit® tox™ Acetaminophen AssaySiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768005787Dimension® Flex® reagent cartridge ACTMSiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768015014Dimension Vista® Flex® reagent cartridge ACTMSiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768023330Emit® tox™ Acetaminophen AssaySiemens Healthcare Diagnostics Inc.LDP2016-09-24
00884883001169DRI Acetaminophen Serum Tox AssayMicrogenics CorporationLDP2016-09-24
00884883001176DRI Acetaminophen Serum Tox CalibratorsMicrogenics CorporationLDP2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen ReagentsSiemens Healthcare Diagnostics Inc.LDP2016-09-24
04015630981205AcetaminophenRoche Diagnostics GmbHLDP2016-09-23
00657498000427Acetaminophen Liquicolor®STANBIO LABORATORY, L.P.LDP2016-09-23
00899722002757Alere Triage®Alere San Diego, Inc.LDP2016-09-21
04015630935031ONLINE TDM Acetaminophen Gen2Roche Diagnostics GmbHLDP2016-09-20
04015630946372AcetaminophenRoche Diagnostics GmbHLDP2016-09-20
00628063400027ACETAMINOPHEN L3KSEKISUI DIAGNOSTICS, LLCLDP2016-09-20
00893038002135Alere Triage®Alere San Diego, Inc.LDP2016-09-19
00628063400034ACETAMINOPHEN L3KSEKISUI DIAGNOSTICS, LLCLDP2016-09-16
05055273208139ACERANDOX LABORATORIES LIMITEDLDP2016-09-09
00380740003661ARCHITECTABBOTT LABORATORIESLDP2016-09-09
15099590229962SynchronBeckman Coulter, Inc.LDP2016-08-24