FDA.reportPublic FDA data

VITROS

Primary DI
10758750006793
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6801728
Catalog number
6801728
Device description
VITROS Chemistry Products dLDL 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
MRRSYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041720000VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND IIOrtho-Clinical Diagnostics, Inc.2004-08-25MRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750006790PackageGS136In Commercial Distribution
10758750006793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000679020758750006790
1075875000679310758750006793

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from light
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
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
10673486002010Teco Diagnostics Direct LDL Cholesterol Reagent SetTECO DIAGNOSTICSMRR2023-11-13
06971674860587BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860594BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860600BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860617BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860624BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860631BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860648BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860655BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860662BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860679BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860686BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860693BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860709BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860716BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860723BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860730BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860747BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860754BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860761BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
05055273213966DIRECT LDL-CHOLESTEROL (LDL)RANDOX LABORATORIES LIMITEDMRR2022-10-04
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024487CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024623CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00630414611037Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08
00630414305073Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08