LSR — Reagent, Borrelia Serological Reagent Class II
FDA product code LSR covers "Reagent, Borrelia Serological Reagent", a Class II medical device regulated under 21 CFR 866.3830. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LSR
- Device Class
- Class II
- Regulation Number
- 866.3830
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254295 | ortho-clinical diagnostics, inc. (quidelortho) | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | July 10, 2026 |
| 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 |
| K203296 | gold standard diagnostics | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | March 22, 2021 |
| 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 |
| 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 |