Axis-Shield Diagnostics Limited
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories4
Latest FDA decision2019-08-02
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K183088 | ADVIA Centaur Erythropoietin (EPO) assay | GGT | 2019-08-02 | View |
| 510(k) | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | JKR | 2018-12-21 | View |
| 510(k) | K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | NHX | 2016-08-04 | View |
| 510(k) | K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | CDD | 2016-07-26 | View |
No matching devices.