FDA.reportPublic FDA data

VITROS

Primary DI
10758750031757
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6844291
Catalog number
6844291
Device description
VITROS XT Chemistry Products ALTV-AST Slides
Published
2020-05-16
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
CKANADH OXIDATION/NAD REDUCTION, ALT/SGPT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750031754PackageGS130In Commercial Distribution
10758750031757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003175420758750031754
1075875003175710758750031757

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, Specify00Can also store 2-8 for up to 3m
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
Premarket exempt
true
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
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
07613336130513Alanine Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCKA2024-01-26
00850053916021IDG/SANZAYIDG/SANZAY CorporationCKA2024-01-03
10673486001082ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001099ALT (SGPT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCKA2023-07-17
10673486001105ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001112ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
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06971674862048BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
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06971674862086BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
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06971674862178BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862185BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862192BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862208BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-10-18
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19