Devices descending from K894293
7 later devices reach Mardx Lyme Disease Eia (Igm) Test System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2021 | 0 | — |
| +1 | K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2020 | 0 | — |
| +1 | K081362 | Platelia Lyme Igm | Bio-Rad | 2008 | 4 | — |
| +2 | K122979 | Vidas Lyme Igm | Biomerieux S.A. | 2013 | 3 | — |
| +3 | K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Quidel Corporation | 2018 | 1 | — |
| +3 | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2017 | 0 | — |
| +4 | K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026 | 0 | — |