FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge MMB

Primary DI
00842768015328
Brand
Dimension Vista® Flex® reagent cartridge MMB
Company
Siemens Healthcare Diagnostics Inc.
Model
10445097
Catalog number
K6420
Device description
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 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
JHYCOLORIMETRIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHYColorimetric Method, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143720000Dimension Vista MMB AssaySiemens Healthcare Diagnostics2015-09-18JHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015328PrimaryGS10
00630414004723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015328008427680153288427680153280842768015328
00630414004723006304140047236304140047230630414004723

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using a chemiluminescent immunoassay method.

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
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870020655CK-MB AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JHY2019-02-11
00816870020662CK-MB AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JHY2019-02-11
00816870022338Monobind AccuLite CKMB CLIA Kit - 96 WellsMONOBIND, INC.JHY2019-02-11
00816870022345CK-MB AccuLite CLIA Test System - 192 WellsMONOBIND, INC.JHY2019-02-11
04015630939978Elecsys CK-MBRoche Diagnostics GmbHJHY2017-04-21
04015630939534CalSet CK-MBRoche Diagnostics GmbHJHY2017-04-17
M525552612SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATIONJHY2017-02-10
15099590011468AUBeckman Coulter, Inc.JHY2016-09-24
00842768013829Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.JHY2016-09-24
00842768013898Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.JHY2016-09-24
04015630928729Elecsys CKMB STAT CalSetRoche Diagnostics GmbHJHY2016-09-20
04015630934638Elecsys CKMB STAT ImmunoassayRoche Diagnostics GmbHJHY2016-09-20
04015630934621Elecsys CKMB ImmunoassayRoche Diagnostics GmbHJHY2016-09-20
M5255516740Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255517650Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255520150SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255520280SPIFE CK Reagent KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255523960QuickGel CK Vis Gel KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255525890Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255525900Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07