| K252627 | inanovate | Lyme-ID IgG Test; Bio-ID800 | November 14, 2025 |
| K242872 | id-fish technology | iDart Lyme IgM ImmunoBlot Kit | June 12, 2025 |
| K233367 | id-fish technology | iDart Lyme IgG ImmunoBlot Kit | August 12, 2024 |
| K230863 | zeus scientific | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl | July 13, 2023 |
| K220016 | viramed biotech | Viramed Borrela All-In-One ViraChip Test Kit | August 19, 2022 |
| K203289 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | March 22, 2021 |
| K203292 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | March 22, 2021 |
| K203296 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | March 22, 2021 |
| K203295 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | March 22, 2021 |
| K202573 | diasorin | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | February 18, 2021 |
| K202574 | diasorin | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | February 18, 2021 |
| K200023 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | April 6, 2020 |
| K200025 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | April 6, 2020 |
| K193051 | diasorin | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | January 29, 2020 |
| K190907 | zeus scientific | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo | July 29, 2019 |
| K191240 | zeus scientific | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo | July 29, 2019 |
| K191398 | zeus scientific | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo | July 29, 2019 |
| K183446 | bio-rad laboratories | BioPlex 2200 Lyme Total | March 12, 2019 |
| K173496 | quidel corporation | Sofia 2 Lyme FIA, Sofia Lyme Control Set | August 30, 2018 |
| K180264 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | May 2, 2018 |