Axis-Shield Diagnostics, Ltd.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest Approval2026-02-18
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253539 | Alere NT-proBNP for Alinity i | NBC | 2026-02-18 | View |
| 510(k) | K241176 | Alere NT-proBNP for Alinity i Reagent Kit | NBC | 2025-01-16 | View |
| 510(k) | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | CDD | 2024-07-31 | View |
| 510(k) | K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | CDD | 2017-10-27 | View |
No matching devices.