FDA.reportPublic FDA data

VITROS

Primary DI
10758750006885
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6801739
Catalog number
6801739
Device description
VITROS Chemistry Products hsCRP Reagent
Published
2016-08-26
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
NQDCARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041799000VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FSOrtho-Clinical Diagnostics, Inc.2004-08-25NQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750006882PackageGS136In Commercial Distribution
10758750006885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000688220758750006882
1075875000688510758750006885

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].

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
00630414611112Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
00630414305028Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
07613336121207Cardiac C-Reactive Protein (Latex) High SensitiveRoche Diagnostics GmbHNQD2020-03-05
00380740180331AlinityABBOTT LABORATORIESNQD2020-01-13
00380740181024AlinityABBOTT LABORATORIESNQD2020-01-13
00380740158491ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00380740158507ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00630414596174Atellica CH hsCRPSiemens Healthcare Diagnostics Inc.NQD2017-12-21
15099590010959AUBeckman Coulter, Inc.NQD2016-09-24
00842768006135Dimension Vista hsCRP Flex reagent cartridgeSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768007729CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768007736CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768016028Dimension CardioPhase high sensitivity CRP Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.NQD2016-09-24
00630414552699ADVIA Chemistry CardioPhase High Sensitivity C-Reactive ProteinSiemens Healthcare Diagnostics Inc.NQD2016-09-24
00630414953144IMMULITE® Systems CRP CONTROL C-Reactive ProteinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414953670IMMULITE®/IMMULITE® 1000 Systems CRP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414953687IMMULITE® 2000 Systems CRP CRP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414961200IMMULITE® 2000 Systems hsC High Sensitivity CRPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414963792IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
04015630912209Tinaquant Cardiac Creactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
04015630921508Cardiac CReactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
04015630928774Cardiac CReactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
15099590203160IMMAGEBeckman Coulter, Inc.NQD2016-08-24
15099590228682SynchronBeckman Coulter, Inc.NQD2016-08-24