FDA.reportPublic FDA data

Gentian Cystatin C Single Use Control Low

Primary DI
07090038460115
Brand
Gentian Cystatin C Single Use Control Low
Company
Gentian AS
Model
1029
Device description
The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay.
Published
2016-11-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K071388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071388000GENTIAN CYSTATIN C IMMUNOASSAYGentian AS2007-11-06NDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07090038460115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090038460115070900384601157090038460115

GMDN Terms#

Term, Definition table
TermDefinition
Cystatin C IVD, controlA material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
730958121
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
07090038460122Gentian Cystatin C Single Use Control High10302016-11-18
17090038460013Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300)1103 / B081792016-09-24
17090038460020Gentian Cystatin C Control Kit (2 x 1mL)1019 / A527652016-09-24
17090038460037Gentian Cystatin C Calibrator Kit1051 / A527632016-09-24
17090038460051Gentian Cystatin C Reagent Beckman Coulter UDR Kit1100 / A527612016-09-24
07090038460061Gentian Cystatin C Reagent Kit11012016-09-24
07090038460078Gentian Cystatin C Control Kit (2 x 1mL)10192016-11-24
07090038460085Gentian Cystatin C Control Kit (2 x 5mL)10262016-11-24
07090038460092Gentian Cystatin C Calibrator10122016-11-24
07090038460108Gentian Cystatin C Calibrator Kit10512016-11-24

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
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
00842768006104DImension Vista® Cystatin C Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHNDY2016-09-24
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