NDY — Test, Cystatin C Class II

FDA Device Classification

Classification Details

Product Code
NDY
Device Class
Class II
Regulation Number
862.1225
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242585sentinel chCystatin CMay 16, 2025
K181082siemens healthcare diagnosticsADVIA Chemistry Cystatin C_2 Assay (CYSC_2)May 25, 2018
K171072siemens healthcare diagnostics productsN Latex Cystatin C; N Protein Standard UYMay 12, 2017
K161817roche diagnostics operations (rdo)Tina-quant Cystatin C Gen.2July 27, 2016
K141143roche diagnosticsCOBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTAJuly 17, 2014
K111664diazyme laboratoriesDIAZYME CYSTATIN C POC TEST KITMarch 30, 2012
K093137kamiya biomedicalK-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLSeptember 28, 2010
K093960tosoh bioscienceST AIA-PACK CYSTATIN C, MODEL 025217September 14, 2010
K093680diazyme laboratoriesDIAZYME CYSTATIN C ASSAYApril 8, 2010
K083906siemens healthcare diagnosticsADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELMarch 11, 2009
K081875gentianGENTIAN CYSTATIN C IMMUNOASSAYAugust 20, 2008
K080811roche diagnosticsTINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN CJune 20, 2008
K080384binding siteHUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSERJune 6, 2008
K080662genzyme corporationGENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATORMay 15, 2008
K072270diazyme laboratoriesDIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ1February 1, 2008
K072166binding siteCYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERJanuary 24, 2008
K071388gentianGENTIAN CYSTATIN C IMMUNOASSAYNovember 6, 2007
K063647thermo electronCYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGHMarch 12, 2007
K063351dade behringDIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CJanuary 22, 2007
K041627dakoCYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORSeptember 3, 2004