FDA.reportPublic FDA data

VITROS

Primary DI
10758750005154
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8748220
Catalog number
8748220
Device description
VITROS Chemistry Products Isoenzyme Performance Verifier II
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
JHSDIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHSDifferential Rate Kinetic Method, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861387000KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)Eastman Kodak Company1986-06-27JHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750005154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000515410758750005154

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414293592Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2020-05-31
00630414294148Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2020-05-31
10758750005123VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2020-04-18
07613336121122Creatine KinaseRoche Diagnostics GmbHJHS2020-03-05
00630414598598Atellica IM CKMB CalibratorSiemens Healthcare Diagnostics Inc.JHS2018-02-06
00630414598604Atellica IM CKMB DILSiemens Healthcare Diagnostics Inc.JHS2018-02-06
00630414598581Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2017-12-27
00630414598574Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2017-12-22
04015630940813Creatine KinaseRoche Diagnostics GmbHJHS2016-12-12
00842768025525Dimension® Flex® reagent cartridge CKISiemens Healthcare Diagnostics Inc.JHS2016-09-24
00842768027918Dimension Vista® Flex® reagent cartridge MBISiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414124803ADVIA Centaur® Systems, ACS:180® Systems CKMB CalibratorSiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414175324ADVIA Centaur® CKMB DiluentSiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414177434ADVIA Centaur® CKMBSiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414177441ADVIA Centaur® CKMBSiemens Healthcare Diagnostics Inc.JHS2016-09-24
04015630940806Creatine KinaseRoche Diagnostics GmbHJHS2016-09-20
04015630921041CKL Creatine KinaseRoche Diagnostics GmbHJHS2016-09-20
04015630921058Creatine KinaseMBRoche Diagnostics GmbHJHS2016-09-20
04015630926831Creatine KinaseMBRoche Diagnostics GmbHJHS2016-09-20
04015630926909Creatine kinaseRoche Diagnostics GmbHJHS2016-09-20
08058056680297CKMB UDRSENTINEL CH. SPAJHS2016-09-16
10758750004201VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2016-08-23
10758750004294VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2016-08-23