Devices descending from K894224
8 later devices reach Mardx Lyme Disease Eia (Igg) Test System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2021 | 0 | — |
| +1 | K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2020 | 0 | — |
| +1 | K080012 | Platelia Lyme Igg Assay | Bio-Rad | 2008 | 5 | — |
| +2 | K122986 | Vidas Lyme Igg | Biomerieux S.A. | 2013 | 4 | — |
| +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 | — |
| +3 | K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS… | Biomerieux | 2015 | 0 | 4 |
| +4 | K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026 | 0 | — |