Product code NDY
- Device name
- Test, Cystatin C
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1225
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242585 | Cystatin C | SENTINEL CH. SpA | 2025-05-16 |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 |
| K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | 2017-05-12 |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016-07-27 |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Roche Diagnostics | 2014-07-17 |
| K111664 | DIAZYME CYSTATIN C POC TEST KIT | Diazyme Laboratories | 2012-03-30 |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Kamiya Biomedical Co. | 2010-09-28 |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | 2010-09-14 |
| K093680 | DIAZYME CYSTATIN C ASSAY | Diazyme Laboratories | 2010-04-08 |
| K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | Siemens Healthcare Diagnostics | 2009-03-11 |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2008-08-20 |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Roche Diagnostics Corp. | 2008-06-20 |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | 2008-06-06 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | 2008-05-15 |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | Diazyme Laboratories | 2008-02-01 |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site | 2008-01-24 |
| K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2007-11-06 |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | Thermo Electron OY | 2007-03-12 |
| K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | Dade Behring, Inc. | 2007-01-22 |
| K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | Dako A/S | 2004-09-03 |
| K041878 | N LATEX CYSTATIN | Dade Behring, Inc. | 2004-08-16 |
| K003503 | N LATEX CYSTATIN C | Dade Behring, Inc. | 2001-03-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08058056685421 | Cystatin C | SENTINEL CH. SPA | 2025-09-16 |
| 08058056685414 | Cystatin C | SENTINEL CH. SPA | 2025-09-16 |
| 07613336133644 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00630414595573 | Atellica™ CH CysC | Siemens Healthcare Diagnostics Inc. | 2019-02-09 |
| 07090038460108 | Gentian Cystatin C Calibrator Kit | Gentian AS | 2016-11-24 |
| 07090038460092 | Gentian Cystatin C Calibrator | Gentian AS | 2016-11-24 |
| 07090038460085 | Gentian Cystatin C Control Kit (2 x 5mL) | Gentian AS | 2016-11-24 |
| 07090038460078 | Gentian Cystatin C Control Kit (2 x 1mL) | Gentian AS | 2016-11-24 |
| 07090038460122 | Gentian Cystatin C Single Use Control High | Gentian AS | 2016-11-18 |
| 07090038460115 | Gentian Cystatin C Single Use Control Low | Gentian AS | 2016-11-18 |
| 04560189212206 | ST AIA-PACK Cyctatin C Sample Dilting Solution | TOSOH CORPORATION | 2016-09-24 |
| 00842768007934 | N Latex Cystatin C | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006104 | DImension Vista® Cystatin C Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 07090038460061 | Gentian Cystatin C Reagent Kit | Gentian AS | 2016-09-24 |
| 05051700017909 | Optilite Cystatin C Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700011624 | Human Cystatin C Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 17090038460051 | Gentian Cystatin C Reagent Beckman Coulter UDR Kit | Gentian AS | 2016-09-24 |
| 17090038460037 | Gentian Cystatin C Calibrator Kit | Gentian AS | 2016-09-24 |
| 17090038460020 | Gentian Cystatin C Control Kit (2 x 1mL) | Gentian AS | 2016-09-24 |
| 17090038460013 | Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300) | Gentian AS | 2016-09-24 |
| 14560189212173 | ST AIA-PACK Cystatin C | TOSOH CORPORATION | 2016-09-24 |
| 04015630932382 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics GmbH | 2016-09-22 |
| 04015630932405 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630932399 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273208665 | CYSC | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05700572014294 | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 05700572014287 | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 05700572013853 | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 00816426020313 | K-ASSAY® Cystatin C Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00816426020320 | K-ASSAY® Cystatin C Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |