FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge CKI

Primary DI
00842768025525
Brand
Dimension® Flex® reagent cartridge CKI
Company
Siemens Healthcare Diagnostics Inc.
Model
10464511
Catalog number
DF38
Device description
Creatine Kinase Flex® reagent cartridge, 480 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
K081731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081731000DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32Siemens Healthcare Diagnostics2008-08-29CGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768025525PrimaryGS10
00630414005645Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768025525008427680255258427680255250842768025525
00630414005645006304140056456304140056450630414005645

GMDN Terms#

Term, Definition table
TermDefinition
Total creatine kinase (CK) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen, using a spectrophotometry 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
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

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
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