FDA.reportPublic FDA data

VITROS

Primary DI
10758750031788
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6844294
Catalog number
6844294
Device description
VITROS XT Chemistry Products UREA-CREA Slides
Published
2019-11-13
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
CDNUREASE, PHOTOMETRIC, UREA NITROGEN
JFYENZYMATIC METHOD, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
JFYEnzymatic Method, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190326000VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.2019-03-14CDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750031785PackageGS130In Commercial Distribution
10758750031788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003178520758750031785
1075875003178810758750031788

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry analytes, in a clinical specimen, which together may create a full general biochemistry profile.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at or below -18
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JFY2024-06-14
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414317434Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
00630414306438ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
17290017272471Minuteful - kidney testHEALTHY.IO LTDJFY2022-11-01
00630414610948Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
00630414301587Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
03610230006962Yumizen C1200 Creatinine PAPHORIBA ABX SASJFY2021-06-17
00811727016072Pointe Creatinine, Enzymatic ReagentHORIBA INSTRUMENTS INCORPORATEDJFY2021-01-30
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JFY2020-09-30
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
00811727015761Pointe Creatinine Enzymatic on BS480HORIBA INSTRUMENTS INCORPORATEDJFY2020-05-28
07613336121160Creatinine plus ver.2Roche Diagnostics GmbHJFY2020-03-05
07070060014630Afinion ACRAbbott Diagnostics Technologies ASJFY2019-05-16
07070060014654Afinion HbA1cAbbott Diagnostics Technologies ASJFY2019-05-16
00386100001995CREA Reagent Kit MEDICA CORPORATIONJFY2019-02-14
00380740136161AlinityABBOTT LABORATORIESJFY2018-08-08
00380740136178AlinityABBOTT LABORATORIESJFY2018-08-08
10673486000573TECO DIAGNOSTICSTECO DIAGNOSTICSJFY2018-02-12
00630414595795Atellica CH ECre_2Siemens Healthcare Diagnostics Inc.JFY2017-12-22