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Dimension Vista® Flex® reagent cartridge MBI

Primary DI
00842768027918
Brand
Dimension Vista® Flex® reagent cartridge MBI
Company
Siemens Healthcare Diagnostics Inc.
Model
10464339
Catalog number
K3032
Device description
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K083465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083465000DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics2009-02-27CGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768027918PrimaryGS10
00630414005577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768027918008427680279188427680279180842768027918
00630414005577006304140055776304140055770630414005577

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using an enzyme immunoassay (EIA) method. Cardiac markers to be assayed 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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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
10758750005154VITROSORTHO-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
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