Panels › Clinical Chemistry › Product code NDY · Class 2
Test, Cystatin C
Regulation 862.1225
0510(k)s in 12 months (22 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in NDY
| Company | 510(k)s | Recalls |
|---|---|---|
| Dade Behring, Inc. | 3 | 0 |
| Diazyme Laboratories | 3 | 0 |
| Gentian AS | 2 | 1 |
| The Binding Site | 2 | 0 |
| Randox Laboratories Ltd. | 0 | 2 |
| Roche Diagnostics | 2 | 0 |
| Siemens Healthcare Diagnostics | 2 | 0 |
| Tosoh Bioscience, Inc. | 1 | 1 |
| Dako A/S | 1 | 0 |
| Genzyme Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2024 | Randox Laboratories Ltd. RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.
Catalogue Number: CYS4004 Open, Classified |
NDY | None listed |
| Mar 22, 2024 | Randox Laboratories Ltd. Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers
Catalog Number: CVS 2699 Open, Classified |
NDY | None listed |
| Sep 2, 2020 | Gentian AS GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models:
1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092
2. Gentian C E Calibrator Kit, 6 x 1 mL, Terminated |
NDY | K071388 K081875 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Cystatin C; Part Number: 025217
Assay, Kidney Marker Terminated |
NDY | K093960 |
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