San Diego, CA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Class II | Immunology | 2 | 2021-08-26 |
| MSV | — | — | — | 1 | 2026-02-06 |
| MID | System, Test, Anticardiolipin Immunological | Class II | Immunology | 1 | 2024-12-17 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Class II | Immunology | 1 | 2023-09-29 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | Class II | Immunology | 1 | 2020-12-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-06 | K243979 | Aptiva APS IgA Reagent | MSV | — | — |
| 2024-12-17 | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | MID | Class II | Immunology |
| 2023-09-29 | K213403 | Aptiva CTD Essential Reagent | LLL | Class II | Immunology |
| 2021-08-26 | K200230 | Aptiva Celiac Disease IgG Reagent | MVM | Class II | Immunology |
| 2021-06-16 | K193604 | Aptiva Celiac Disease IgA Reagent | MVM | Class II | Immunology |
| 2020-12-11 | K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | KTL | Class II | Immunology |