FDA.reportPublic FDA data

DImension Vista® Cystatin C Flex® reagent cartridge

Primary DI
00842768006104
Brand
DImension Vista® Cystatin C Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445895
Catalog number
K7040
Device description
For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System
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
NDYTEST, CYSTATIN C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDYTest, Cystatin CClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063351000DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGHDade Behring, Inc.2007-01-22NDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768006104PrimaryGS10
00842768020001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006104008427680061048427680061040842768006104
00842768020001008427680200018427680200010842768020001

GMDN Terms#

Term, Definition table
TermDefinition
Cystatin C IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen using a nephelometry/turbidimetry 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
388240673
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08058056685414Cystatin CSENTINEL CH. SPANDY2025-09-16
08058056685421Cystatin CSENTINEL CH. SPANDY2025-09-16
07613336133644Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2020-03-05
00630414595573Atellica™ CH CysCSiemens Healthcare Diagnostics Inc.NDY2019-02-09
00630414224916ADVIA Chemistry Cystatin C_2 AssaySiemens Healthcare Diagnostics Inc.NDY2018-09-24
00630414236919Atellica CH CYSC_2Siemens Healthcare Diagnostics Inc.NDY2018-09-24
00630414167824N Latex Cystatin CSiemens Healthcare Diagnostics Products GmbHNDY2017-06-20
07090038460078Gentian Cystatin C Control Kit (2 x 1mL)Gentian ASNDY2016-11-24
07090038460085Gentian Cystatin C Control Kit (2 x 5mL)Gentian ASNDY2016-11-24
07090038460092Gentian Cystatin C CalibratorGentian ASNDY2016-11-24
07090038460108Gentian Cystatin C Calibrator KitGentian ASNDY2016-11-24
07090038460115Gentian Cystatin C Single Use Control LowGentian ASNDY2016-11-18
07090038460122Gentian Cystatin C Single Use Control HighGentian ASNDY2016-11-18
14560189212173ST AIA-PACK Cystatin CTOSOH CORPORATIONNDY2016-09-24
17090038460013Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300)Gentian ASNDY2016-09-24
17090038460020Gentian Cystatin C Control Kit (2 x 1mL)Gentian ASNDY2016-09-24
17090038460037Gentian Cystatin C Calibrator KitGentian ASNDY2016-09-24
17090038460051Gentian Cystatin C Reagent Beckman Coulter UDR KitGentian ASNDY2016-09-24
04560189212206ST AIA-PACK Cyctatin C Sample Dilting SolutionTOSOH CORPORATIONNDY2016-09-24
05051700011624Human Cystatin C Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDNDY2016-09-24
05051700017909Optilite Cystatin C KitTHE BINDING SITE GROUP LIMITEDNDY2016-09-24
07090038460061Gentian Cystatin C Reagent KitGentian ASNDY2016-09-24
00842768007934N Latex Cystatin CSiemens Healthcare Diagnostics Products GmbHNDY2016-09-24
00630414557915ADVIA® Chemistry CYSC Cystatin-C ReagentsSiemens Healthcare Diagnostics Inc.NDY2016-09-24
04015630932382Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2016-09-22
04015630932399Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2016-09-20
04015630932405Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2016-09-20
05055273208665CYSCRANDOX LABORATORIES LIMITEDNDY2016-09-16
05700572013853DakoAGILENT TECHNOLOGIES SINGAPORE PTE LTDNDY2016-09-16
05700572014287Cystatin C Control SetAGILENT TECHNOLOGIES SINGAPORE PTE LTDNDY2016-09-16