Uppsala, SE · 7 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DHB | — | — | — | 2 | 2022-08-03 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Class II | Immunology | 1 | 2026-06-25 |
| LKJ | Antinuclear Antibody, Antigen, Control | Class II | Immunology | 1 | 2022-07-27 |
| NYO | — | — | — | 1 | 2021-09-13 |
| MQA | — | — | — | 1 | 2021-09-13 |
| LKP | Anti-Sm Antibody, Antigen And Control | Class II | Immunology | 1 | 2021-07-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-05-24 | Class II | Ongoing | Z-0783-2024 | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic | — | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution rea… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-25 | K253367 | EliA CTD 13 Screen | LLL | Class II | Immunology |
| 2022-08-03 | K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed | DHB | — | — |
| 2022-07-27 | K210902 | EliA Ro52, EliA Ro60 | LKJ | Class II | Immunology |
| 2021-09-13 | K202541 | EliA RNA Pol III | NYO | — | — |
| 2021-09-13 | K202540 | EliA Rib-P | MQA | — | — |
| 2021-07-14 | K202067 | EliA SmDP-S | LKP | Class II | Immunology |
| 2020-05-01 | K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | DHB | — | — |