Home › Device types › LSR
Reagent, Borrelia Serological Reagent
FDA product code LSR · Class 2 · Microbiology
128
Registered devices
135
Adverse events
5
Recalls
112
510(k) clearances
Devices with this code
Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Lyme ELISA (IgG/IgM) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — MARDX DIAGNOSTICS, INC.Borrelia B31 IgM ViraStripe® Test Kit — Viramed Biotech AGBorrelia B31 ViraChip® IgM Test Kit — Viramed Biotech AGGold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit — Gold Standard Diagnostics CorporationTrinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.ACCURUN® — Lgc Clinical Diagnostics, Inc.Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit — Gold Standard Diagnostics CorporationMarDx — CLARK LABORATORIES, INC.Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit — Gold Standard Diagnostics CorporationTrinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) — EUROIMMUN Medizinische Labordiagnostika AGPLATELIA — BIO-RADImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit — Gold Standard Diagnostics CorporationBio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2013-02-11 | Innominata Dba Genbio | Multiple incidents of low-reacting assay plates. |
| 2003-10-28 | Biomerieux, Inc. | Kit may contain incorrect components |
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