Product code LSR
- Device name
- Reagent, Borrelia Serological Reagent
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3830
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | 2025-11-14 |
| K242872 | iDart Lyme IgM ImmunoBlot Kit | Id-Fish Technology, Inc. | 2025-06-12 |
| K233367 | iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. | 2024-08-12 |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific | 2023-07-13 |
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | 2022-08-19 |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021-02-18 |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021-02-18 |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2020-04-06 |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2020-04-06 |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | 2020-01-29 |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Zeus Scientific, Inc. | 2019-07-29 |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Zeus Scientific, Inc. | 2019-07-29 |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Zeus Scientific, Inc. | 2019-07-29 |
| K183446 | BioPlex 2200 Lyme Total | Bio-Rad Laboratories | 2019-03-12 |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2018-08-30 |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2018-05-02 |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Quidel Corporation | 2018-02-28 |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | Euroimmun Us, Inc. | 2017-12-10 |
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | Trinity Biotech | 2017-10-23 |
| K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2017-10-20 |
| K163695 | Borrelia B31 ViraChip IgM Test Kit | Viramed Biotech AG | 2017-08-22 |
| K163504 | Borrelia B31 ViraChip IgG Test Kit | Viramed Biotech AG | 2017-07-12 |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | Trinity Biotech | 2017-02-01 |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | Euroimmun US | 2016-08-25 |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | Euroimmun US | 2015-05-04 |
| K122979 | VIDAS LYME IGM | Biomerieux S.A. | 2013-06-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845533002950 | Anti-Borrelia VlsE1/pepC10 IgG/IgM | ZEUS SCIENTIFIC, INC. | 2026-02-18 |
| 00850049545259 | AccuDiag ™ | Diagnostic Automation, Inc. | 2024-03-06 |
| 00850054026378 | QMedix™ | Diagnostic Automation, Inc. | 2024-01-31 |
| 04048474028119 | Borrelia burgdorferi IgM (Lyme) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474028102 | Borrelia burgdorferi IgG (Lyme) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474028096 | B. burgdorferi IgG/IgM ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239028112 | Borrelia burgdorferi IgM (Lyme) ELISA | DRG International Inc | 2023-08-24 |
| 00840239028105 | Borrelia burgdorferi IgG (Lyme) ELISA | DRG International Inc | 2023-08-24 |
| 00840239028099 | B. burgdorferi IgG/IgM ELISA | DRG International Inc | 2023-08-24 |
| EVIRBTCFDK1 | Borrelia All-In-One ViraChip Deca Kit | Viramed Biotech AG | 2022-11-08 |
| EVIRBTCFOK1 | Borrelia All-In-One ViraChip Test Kit | Viramed Biotech AG | 2022-11-08 |
| B350GSD0110310 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-10-28 |
| B350GSD0110250 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-09-24 |
| B350GSD0110260 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-09-24 |
| 00845533001854 | ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System | ZEUS SCIENTIFIC, INC. | 2022-04-27 |
| 00894175000022 | AccuDiag ™ | Diagnostic Automation, Inc. | 2021-08-10 |
| B350GSD0110270 | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit | Gold Standard Diagnostics Corporation | 2021-07-20 |
| B350GSD0110220 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit | Gold Standard Diagnostics Corporation | 2020-07-01 |
| B350GSD0110230 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | Gold Standard Diagnostics Corporation | 2020-07-01 |
| 05391516747547 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-08-06 |
| 05391516747134 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-08-06 |
| 03610520506394 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2019-05-13 |
| 05391516747943 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747929 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747738 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747585 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 03573026458270 | VIDAS® Lyme IgG II | BIOMERIEUX SA | 2016-08-31 |
| 03573026447151 | VIDAS® Lyme IgM II | BIOMERIEUX SA | 2016-08-31 |
| 03610520007877 | PLATELIA | BIO-RAD | 2016-08-16 |
| 03610520007860 | PLATELIA | BIO-RAD | 2016-08-16 |