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
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit — Gold Standard Diagnostics CorporationMarDx — CLARK LABORATORIES, INC.MarDx — CLARK LABORATORIES, INC.AccuDiag ™ — Diagnostic Automation, Inc.Trinity Biotech — MARDX DIAGNOSTICS, INC.Borrelia B31 ViraChip® IgM Test Kit — Viramed Biotech AGGold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit — Gold Standard Diagnostics CorporationBorrelia B31 IgG ViraStripe® Test Kit — Viramed Biotech AGGold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit — Gold Standard Diagnostics CorporationImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.AccuDiag ™ — Diagnostic Automation, Inc.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.PLATELIA — BIO-RADTrinity Biotech — MARDX DIAGNOSTICS, INC.Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit — Gold Standard Diagnostics CorporationBorrelia B31 IgG ViraStripe® Deca Kit — Viramed Biotech AGTrinity Biotech — CLARK LABORATORIES, INC.Borrelia All-In-One ViraChip Test Kit — Viramed Biotech AGTrinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — CLARK LABORATORIES, INC.VIDAS® Lyme IgG and IgM — BIOMERIEUX SAAnti-Borrelia VlsE1/pepC10 IgG/IgM — ZEUS SCIENTIFIC, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, 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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