LSR — Reagent, Borrelia Serological Reagent Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K252627inanovateLyme-ID IgG Test; Bio-ID800November 14, 2025
K242872id-fish technologyiDart Lyme IgM ImmunoBlot KitJune 12, 2025
K233367id-fish technologyiDart Lyme IgG ImmunoBlot KitAugust 12, 2024
K230863zeus scientificZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlJuly 13, 2023
K220016viramed biotechViramed Borrela All-In-One ViraChip Test KitAugust 19, 2022
K203289gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitMarch 22, 2021
K203292gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitMarch 22, 2021
K203296gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitMarch 22, 2021
K203295gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitMarch 22, 2021
K202573diasorinLIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusFebruary 18, 2021
K202574diasorinLIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusFebruary 18, 2021
K200023gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitApril 6, 2020
K200025gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitApril 6, 2020
K193051diasorinLIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetJanuary 29, 2020
K190907zeus scientificZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdoJuly 29, 2019
K191240zeus scientificZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdoJuly 29, 2019
K191398zeus scientificZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdoJuly 29, 2019
K183446bio-rad laboratoriesBioPlex 2200 Lyme TotalMarch 12, 2019
K173496quidel corporationSofia 2 Lyme FIA, Sofia Lyme Control SetAugust 30, 2018
K180264gold standard diagnosticsGold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitMay 2, 2018