FDA.reportPublic FDA data

VITROS

Primary DI
10758750031795
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6844295
Catalog number
6844295
Device description
VITROS XT Chemistry Products GLU-Ca 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
CGAGLUCOSE OXIDASE, GLUCOSE
CJYAZO DYE, CALCIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CJYAzo Dye, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190520000VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.2019-04-03CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750031792PackageGS130In Commercial Distribution
10758750031795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003179220758750031792
1075875003179510758750031795

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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