FDA.reportPublic FDA data

VITROS

Primary DI
10758750002610
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6802327
Catalog number
6802327
Device description
VITROS Chemistry Products DAT Performance Verifier I
Published
2020-05-29
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
DIFDrug mixture control materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062123000VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVOrtho-Clinical Diagnostics, Inc.2006-11-16DIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750002617PackageGS136In Commercial Distribution
10758750002610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000261720758750002617
1075875000261010758750002610

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
00690286000742MEDTOX®MEDTOX DIAGNOSTICS, INC.DIF2026-03-31
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00810042684423DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684430DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684447DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
00810042683822DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-02-20
00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684348DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
00810042684263DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684270DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684287DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684294DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684300DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684317DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684249DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684256DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684232iScreenBIOCHEMICAL DIAGNOSTICS INCDIF2024-07-22
00810042683976DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683983DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683990DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684003DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684010DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684027DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684034DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684041DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684058DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684065DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12