Reagent, Borrelia Serological Reagent
FDA product code LSR · Class II (moderate risk) · 21 CFR 866.3830 · Microbiology
112510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Zeus Scientific, Inc. 13
- Gold Standard Diagnostics 9
- Viramed Biotech AG 7
- Mardx Diagnostics, Inc. 6
- Whittaker Bioproducts, Inc. 4
- Boston Biomedica, Inc. 4
- DiaSorin, Inc. 4
- General Biometrics, Inc. 4
- Diamedix Corp. 4
- Medical Diagnostic Technologies, Inc. 4
- Hillcrest Biologicals 4
- Inova Diagnostics, Inc. 3
- Immunetics, Inc. 3
- Euroimmun Us, Inc. 3
- Quidel Corp. 3
- Trinity Biotech USA 2
- Columbia Bioscience, Inc. 2
- Genbio 2
- Wampole Laboratories 2
- Cambridge Biotech Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIALSR · Traditional | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 07/10/2026SE |
| K252627 | Lyme-ID IgG Test; Bio-ID800LSR · Traditional | Inanovate, Inc. | 11/14/2025SE |
| K242872 | iDart Lyme IgM ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 06/12/2025SE |
| K233367 | iDart Lyme IgG ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 08/12/2024SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | Zeus Scientific | 07/13/2023SE |
| K220016 | Viramed Borrela All-In-One ViraChip Test KitLSR · Traditional | Viramed Biotech AG | 08/19/2022SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | DiaSorin, Inc. | 02/18/2021SE |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | DiaSorin, Inc. | 02/18/2021SE |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 04/06/2020SE |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 04/06/2020SE |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetLSR · Traditional | DiaSorin, Inc. | 01/29/2020SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | Zeus Scientific, Inc. | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | Zeus Scientific, Inc. | 07/29/2019SE |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | Zeus Scientific, Inc. | 07/29/2019SE |
| K183446 | BioPlex 2200 Lyme TotalLSR · Traditional | Bio-Rad Laboratories | 03/12/2019SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | Quidel Corporation | 08/30/2018SE |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 05/02/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | Quidel Corporation | 02/28/2018SE |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR · Traditional | Euroimmun Us, Inc. | 12/10/2017SE |
| K172254 | Lyme B. burgdorferi (IgM) MarStripe TestLSR · Traditional | Trinity Biotech | 10/23/2017SE |
| K163713 | Sofia Lyme FIA, Sofia Lyme Control SetLSR · Traditional | Quidel Corporation | 10/20/2017SE |
| K163695 | Borrelia B31 ViraChip IgM Test KitLSR · Traditional | Viramed Biotech AG | 08/22/2017SE |
| K163504 | Borrelia B31 ViraChip IgG Test KitLSR · Traditional | Viramed Biotech AG | 07/12/2017SE |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe TestLSR · Traditional | Trinity Biotech | 02/01/2017SE |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG)LSR · Traditional | Euroimmun US | 08/25/2016SE |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM)LSR · Traditional | Euroimmun US | 05/04/2015SE |
| K122979 | Vidas Lyme IgmLSR · Traditional | Biomerieux S.A. | 06/04/2013SE |
| K122986 | Vidas Lyme IggLSR · Traditional | Biomerieux S.A. | 03/05/2013SE |
| K113397 | Zeus Elisa Borrelia VLSE-1/PEPC10 Igg/Igm Test SystemLSR · Traditional | Zeus Scientific, Inc. | 07/26/2012SE |
| K113846 | Borrelia Burgdorferi Igm Blot TestLSR · Traditional | Gold Standard Diagnostics | 06/01/2012SE |
| K113847 | Borrelia Burgdorferi Igg Blot TestLSR · Traditional | Gold Standard Diagnostics | 04/11/2012SE |
| K100728 | Athena Multi-Lyte Borrelia VLSE-1/PEPC10 Plus Test SystemLSR · Traditional | Zeus Scientific, Inc. | 07/06/2010SE |
| K092693 | Viramed Biotech AG Borrelia B31 Igg Virastripe, Model V-BbsgusLSR · Traditional | Viramed Biotech AG | 11/25/2009SE |
| K082329 | Viramed Biotech AG Borrelia B31 Igm VirastripeLSR · Traditional | Viramed Biotech AG | 08/05/2009SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | Bio-Rad | 06/26/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | Bio-Rad | 05/08/2008SE |
| K062473 | Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871LSR · Traditional | DiaSorin, Inc. | 04/12/2007SE |
| K051169 | Biramed Biotech Borrelia B31 Igm VirablotLSR · Traditional | Viramed Biotech AG | 08/11/2005SE |
| K051071 | Viramed Biotech Borrelia B31 Igg VirablotLSR · Traditional | Viramed Biotech AG | 08/11/2005SE |
| K033083 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | Trinity Biotech USA | 11/26/2003SE |
| K033070 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | Trinity Biotech USA | 11/26/2003SE |
| K032713 | Boston Biomedica, Inc. Borrelia Burgdorferi Igm and IggLSR · Traditional | Boston Biomedica, Inc. | 11/24/2003SE |
| K003754 | Immunetics C6 Lyme Elisa KitLSR · Traditional | Immunetics, Inc. | 05/10/2001SE |
| K994004 | Quanta Lite Lyme B. Burgdorferi Igg/Igm Elisa KitLSR · Traditional | Inova Diagnostics, Inc. | 01/27/2000SE |
| K991063 | Qualicode B. Burgdorferi Igg Western Blot Kit, Model DK-C052-024LSR · Traditional | Immunetics, Inc. | 09/21/1999SE |
| K991062 | Qualicode B. Burgdorferi Igm Western Blot Kit, Model DK-C062-024LSR · Traditional | Immunetics, Inc. | 09/21/1999SE |
| K991185 | Borrelia Burgdorferi Igm Western Blot Test SystemLSR · Traditional | Zeus Scientific, Inc. | 09/03/1999SE |
| K991180 | Borrelia Burgdorferi Igg Western Blot Test SystemLSR · Traditional | Zeus Scientific, Inc. | 09/03/1999SE |
| K984234 | Quanta Lite Lyme Igm ElisaLSR · Traditional | Inova Diagnostics, Inc. | 04/15/1999SE |
| K984222 | Quanta Lite Lyme Igg ElisaLSR · Traditional | Inova Diagnostics, Inc. | 04/15/1999SE |
| K984138 | Aptus (Automated) Application for the B. Burgdorferi Antibody Elisa Test SystemLSR · Traditional | Zeus Scientific, Inc. | 03/23/1999SE |
| K980351 | Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitLSR · Traditional | Boston Biomedica, Inc. | 03/05/1999SE |
| K981913 | Prevue(Tm) Borrelia Burgdorferi Antibody Detection AssayLSR · Traditional | Chembio Diagnostic Systems, Inc. | 02/12/1999SE |
| K983606 | Is Borrelia Burgdorferi Igm Test SystemLSR · Traditional | Columbia Bioscience, Inc. | 12/16/1998SE |
| K983605 | Is Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | Columbia Bioscience, Inc. | 12/16/1998SE |
| K971007 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)LSR · Traditional | Mrl Diagnostics | 06/01/1998SE |
| K971006 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)LSR · Traditional | Mrl Diagnostics | 06/01/1998SE |
| K970768 | Human Lyme Igm Western Blot KitLSR · Traditional | Cambridge Diagnostics Ireland, Ltd. | 04/09/1998SE |
| K970761 | Limited Human Lyme Igg Western Blot Kit (Cambridge Diagnostics Ireland)LSR · Traditional | Cambridge Diagnostics Ireland, Ltd. | 04/09/1998SE |
| K971170 | Cambridge Biotech Human Lyme Igm Western Blot (90112)LSR · Traditional | Cambridge Biotech Corp. | 02/17/1998SE |
| K971169 | Cambridge Biotech Human Lyme Igg Western Blot (90111)LSR · Traditional | Cambridge Biotech Corp. | 02/17/1998SE |
| K974810 | Accurun(Tm) 132 Borrelia Burdorferi Igm Positive ControlLSR · Traditional | Boston Biomedica, Inc. | 02/05/1998SE |
| K974809 | Accurun(Tm) 130 Borrelia Burgdorferi Igg Positive ControlLSR · Traditional | Boston Biomedica, Inc. | 02/05/1998SE |
| K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | Wampole Laboratories | 03/26/1997SE |
| K965129 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | Wampole Laboratories | 03/26/1997SE |
| K951709 | Mardx Lyme Disease (Igm) Marblot Strip Test SystemLSR · Traditional | Mardx Diagnostics, Inc. | 06/07/1996SE |
| K950829 | Mardx Lyme Disease (Igg) Marblot Strip Test SystemLSR · Traditional | Mardx Diagnostics, Inc. | 06/05/1996SE |
| K953683 | Mmuno Dot Borrelia Dot Blot M TestLSR · Traditional | Genbio | 05/03/1996SE |
| K953682 | Immuno Dot Borrelia Dot Blot G TestLSR · Traditional | Genbio | 05/03/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | Biomerieux Vitek, Inc. | 06/13/1995SE |
| K922578 | Bartels Lyme Disease Igm EiaLSR · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K911627 | Immunodot Borrelia (Lyme) TestLSR · Traditional | General Biometrics, Inc. | 04/08/1992SE |
| K911599 | Immunowell Lyme (P39 Recombinant) TestLSR · Traditional | General Biometrics, Inc. | 12/30/1991SE |
| K911590 | Immunowell Borrelia (Lyme)TestLSR · Traditional | General Biometrics, Inc. | 12/20/1991SE |
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | Diagnostic Technology, Inc. | 11/05/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | Whittaker Bioproducts, Inc. | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | Whittaker Bioproducts, Inc. | 10/16/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | Vitek Systems, Inc. | 08/30/1991SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | Hillcrest Biologicals | 06/28/1991SE |
| K911496 | Fasttech System 1LSR · Traditional | 3M Diagnostic Systems, Inc. | 06/24/1991SE |
| K903013 | Lyme Igm Elisa TestLSR · Traditional | Gull Laboratories, Inc. | 06/21/1991SE |
| K911330 | Lyme Igm MicroassayLSR · Traditional | Diamedix Corp. | 06/10/1991SE |
| K910899 | Lyme Disease MicroassayLSR · Traditional | Diamedix Corp. | 06/10/1991SE |
| K911145 | Borrelia Burgdorferi Polyval Igg/Igm Antibody TestLSR · Traditional | Medical Diagnostic Technologies, Inc. | 05/10/1991SE |
| K895713 | 3M Igg Fastlyme(Tm) TestLSR · Traditional | 3M Company | 12/14/1990SE |
| K900572 | Lyme Igm MicroassayLSR · Traditional | Diamedix Corp. | 05/02/1990SE |
| K900196 | Lyme Igm Elisa Test SystemLSR · Traditional | Zeus Scientific, Inc. | 05/02/1990SE |
| K901054 | Bion Borrelia Burgdorferi Antigen Substrate SlideLSR · Traditional | Bion Ent., Ltd. | 04/05/1990SE |
| K895292 | Lyme Igg Elisa Test SystemLSR · Traditional | Zeus Scientific, Inc. | 12/13/1989SE |
| K894410 | Immunodot Lyme TestLSR · Traditional | General Biometrics, Inc. | 10/30/1989SE |
| K894609 | Mardx Lyme Disease Ifa (Igm) Test SystemLSR · Traditional | Mardx, Inc. | 09/19/1989SE |
| K894293 | Mardx Lyme Disease Eia (Igm) Test SystemLSR · Traditional | Mardx Diagnostics, Inc. | 08/21/1989SE |
| K894224 | Mardx Lyme Disease Eia (Igg) Test SystemLSR · Traditional | Mardx Diagnostics, Inc. | 08/21/1989SE |
| K892206 | Mardx Llyme Disease Eia (Igg & Igm) Test SystemLSR · Traditional | Mardx Diagnostics, Inc. | 08/15/1989SE |
| K890843 | Lyme Disease MicroassayLSR · Traditional | Diamedix Corp. | 07/25/1989SE |
| K890053 | Mardx Lyme Disease Igg Ifa Test SystemLSR · Traditional | Mardx Diagnostics, Inc. | 04/18/1989SE |
| K885294 | Borrelia Burgdorferi Igm Antibody Test SystemLSR · Traditional | Medical Diagnostic Technologies, Inc. | 04/10/1989SE |
| K885293 | Borrelia Burgdorferi Igg Antibody Test SystemLSR · Traditional | Medical Diagnostic Technologies, Inc. | 04/10/1989SE |
| K885290 | Borrelia Burgdorferi Polyvalent Igg/Igm AntibodyLSR · Traditional | Medical Diagnostic Technologies, Inc. | 04/10/1989SE |
| K890281 | Human Lyme Eia for the Detect of AntibodiesLSR · Traditional | Cambridge Bioscience Corp. | 03/15/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | Hillcrest Biologicals | 03/15/1989SE |
| K885317 | Lyme Elisa Test SystemLSR · Traditional | Zeus Scientific, Inc. | 03/02/1989SE |
| K883544 | Lyme Fast TestLSR · Traditional | 3M Company | 01/13/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | Hillcrest Biologicals | 12/13/1988SE |
| K880476 | Lyme Disease ElisaLSR · Traditional | Hillcrest Biologicals | 04/26/1988SE |
| K875286 | Lyme Stat Test KitLSR · Traditional | Whittaker Bioproducts, Inc. | 03/30/1988SE |
| K872247 | Fiax Test Kit for Lyme Disease AntibodiesLSR · Traditional | Whittaker Bioproducts, Inc. | 10/15/1987SE |
| K871246 | Ifa Test for Antibodies to Borrelia BurgdorferiLSR · Traditional | Zeus Scientific, Inc. | 08/25/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0743-2026 Class II | Lyme TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0437-2022 Class II | VIDAS Lyme IgG II (LYM), REF 417401bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-0436-2022 Class II | VIDAS Lyme IgM II (LYM), REF 416436bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-0927-2013 Class II | ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package…Multiple incidents of low-reacting assay plates. | Innominata Dba Genbio | 02/11/2013Terminated |