Lliçà DAmunt, Barcelona, ES · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MYF | — | — | — | 1 | 2025-02-12 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | Class I | Microbiology | 1 | 2024-08-07 |
| LSE | Epstein-Barr Virus, Other | Class I | Microbiology | 1 | 2024-08-07 |
| MXJ | — | — | — | 1 | 2023-09-20 |
| DGC | Ige, Antigen, Antiserum, Control | Class II | Immunology | 1 | 2023-02-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-09-28 | Class II | Ongoing | Z-1021-2023 | biokitHSV-2 Rapid Test, REF: 300028001 | — | HSV-2 rapid test may report false positive results. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-02-12 | K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | MYF | — | — |
| 2024-08-07 | K233606 | ADVIA Centaur EBV-VCA IgM | LSE | Class I | Microbiology |
| 2024-08-07 | K233605 | ADVIA Centaur EBV-EBNA IgG | LLM | Class I | Microbiology |
| 2023-09-20 | K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | MXJ | — | — |
| 2023-02-21 | K214068 | Quantia IgE | DGC | Class II | Immunology |