FDA.reportPublic FDA data

Atellica™ CH CysC

Primary DI
00630414595573
Brand
Atellica™ CH CysC
Company
Siemens Healthcare Diagnostics Inc.
Model
11097636
Catalog number
11097636
Device description
Cystatin C (CysC) Atellica™ CH - RGT 800T
Published
2019-02-09
Public version status
Update
Distribution status
Not 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
K083906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083906000ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487Siemens Healthcare Diagnostics2009-03-11NDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414595573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414595573006304145955736304145955730630414595573

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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
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
08058056685414Cystatin CSENTINEL CH. SPANDY2025-09-16
08058056685421Cystatin CSENTINEL CH. SPANDY2025-09-16
07613336133644Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2020-03-05
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