FDA.reportPublic FDA data

VITROS

Primary DI
10758750006861
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6801737
Catalog number
6801737
Device description
VITROS Chemistry Products ApoA1 Reagent
Published
2020-04-18
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
MSJAPOLIPOPROTEINS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSJApolipoproteinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042521000VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics, Inc.2004-11-18JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750006868PackageGS136In Commercial Distribution
10758750006861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000686820758750006868
1075875000686110758750006861

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen, using a nephelometry/turbidimetry method.

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
00817089022478DiazymeDIAZYME LABORATORIES, INC.MSJ2026-01-21
06971674866664BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674866671BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674866688BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674867920BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674868255BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674860778BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860785BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860792BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860808BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860815BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860822BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860839BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860846BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860853BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860860BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860877BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860884BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860891BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860907BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860914BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860921BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860938BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860945BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860952BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860969BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860976BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860983BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860990BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861003BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20