FDA.reportPublic FDA data

Cystatin C

Primary DI
08058056685414
Brand
Cystatin C
Company
SENTINEL CH. SPA
Model
06T3220
Catalog number
06T3220
Device description
The Cystatin C assay is an in vitro diagnostic test used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma on the Alinity c system.Measurement of cystatin C aids in the diagnosis and treatment of renal diseases.For laboratory professional use only.
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K242585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242585000Cystatin CSENTINEL CH. SpA2025-05-16NDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056685414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056685414080580566854148058056685414

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

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
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
08058056681232CeruloplasminA26842A268422016-07-29
08058056685391Cystatin C Calibrators06T320106T32012025-09-16
08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
08058056681980Albumin BCP (6x50 mL)C22856C228562020-02-24
08058056685438ARCHITECT c ACE Assay File6U82-1A6U82-1A2025-03-10
08058056685445Alinity c ACE Assay File06U86-1A06U86-1A2025-03-10
08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
08058056685308ACE Reagent06U822506U82252025-01-27
08058056685315ACE Calibrator06U860106U86012025-01-27
08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
08058056680211Lp(a) Ultra11504D11504D2024-03-15
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680181Ammonia Ultra 17660176602023-11-22
08058056680617Lipase Color Liquid17401B17401B2017-01-16
08058056681911CRP Ultra (MP)1156461156462018-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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