ClearanceBrief
Panels › Microbiology › Product code LSR · Class 2

Reagent, Borrelia Serological Reagent

Regulation 866.3830

2510(k)s in 12 months (112 all time)
1recalls in 12 months (5 all time)
2recalls that name a 510(k)
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Top companies in LSR

Company510(k)sRecalls
Zeus Scientific130
Gold Standard Diagnostics90
Viramed Biotech AG70
Mardx Diagnostics, Inc.60
Biomerieux S.A.23
Boston Biomedica, Inc.40
Diamedix Corp.40
DiaSorin, Inc.40
General Biometrics, Inc.40
Hillcrest Biologicals40
Decided510(k)Device and applicantCode
Jul 10, 2026K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIA
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
LSR
Nov 14, 2025K252627Lyme-ID IgG Test; Bio-ID800
Inanovate, Inc.
LSR
Jun 12, 2025K242872iDart Lyme IgM ImmunoBlot Kit
Id-Fish Technology, Inc.
LSR
Aug 12, 2024K233367iDart Lyme IgG ImmunoBlot Kit
Id-Fish Technology, Inc.
LSR
Jul 13, 2023K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Zeus Scientific
LSR
Aug 19, 2022K220016Viramed Borrela All-In-One ViraChip Test Kit
Viramed Biotech AG, DE
LSR
Mar 22, 2021K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Gold Standard Diagnostics
LSR
Mar 22, 2021K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Gold Standard Diagnostics
LSR
Mar 22, 2021K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Gold Standard Diagnostics
LSR
Mar 22, 2021K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
Gold Standard Diagnostics
LSR
Feb 18, 2021K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
DiaSorin, Inc.
LSR
Feb 18, 2021K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
DiaSorin, Inc.
LSR
Apr 6, 2020K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Gold Standard Diagnostics
LSR
Apr 6, 2020K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Gold Standard Diagnostics
LSR
Jan 29, 2020K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
DiaSorin, Inc.
LSR
Jul 29, 2019K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
Zeus Scientific, Inc.
LSR
Jul 29, 2019K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
Zeus Scientific, Inc.
LSR
Jul 29, 2019K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
Zeus Scientific, Inc.
LSR
Mar 12, 2019K183446BioPlex 2200 Lyme Total
Bio-Rad Laboratories
LSR
Aug 30, 2018K173496Sofia 2 Lyme FIA, Sofia Lyme Control Set
Quidel Corporation
LSR
May 2, 2018K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Gold Standard Diagnostics
LSR
Feb 28, 2018K173691Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
Quidel Corporation
LSR
Dec 10, 2017K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Euroimmun Us, Inc.
LSR
Oct 23, 2017K172254Lyme B. burgdorferi (IgM) MarStripe Test
Trinity Biotech
LSR
Oct 20, 2017K163713Sofia Lyme FIA, Sofia Lyme Control Set
Quidel Corporation
LSR
Aug 22, 2017K163695Borrelia B31 ViraChip IgM Test Kit
Viramed Biotech AG, DE
LSR
Jul 12, 2017K163504Borrelia B31 ViraChip IgG Test Kit
Viramed Biotech AG, DE
LSR
Feb 1, 2017K163095Lyme B. burgdorferi (IgG) MarStripe Test
Trinity Biotech
LSR
Aug 25, 2016K161513Anti-Borrelia burgdorferi US Westernblot (IgG)
Euroimmun US
LSR
May 4, 2015K142038EUROIMMUN LYME ELISA(IgG/IgM)
Euroimmun US
LSR
Jun 4, 2013K122979VIDAS LYME IGM
Biomerieux S.A., FR
LSR
Mar 5, 2013K122986VIDAS LYME IGG
Biomerieux S.A., FR
LSR
Jul 26, 2012K113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
Zeus Scientific, Inc.
LSR
Jun 1, 2012K113846BORRELIA BURGDORFERI IGM BLOT TEST
Gold Standard Diagnostics
LSR
Apr 11, 2012K113847BORRELIA BURGDORFERI IGG BLOT TEST
Gold Standard Diagnostics
LSR
Jul 6, 2010K100728ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
Zeus Scientific, Inc.
LSR
Nov 25, 2009K092693VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
Viramed Biotech AG
LSR
Aug 5, 2009K082329VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
Viramed Biotech AG
LSR
Jun 26, 2008K081362PLATELIA LYME IGM
Bio-Rad
LSR
May 8, 2008K080012PLATELIA LYME IGG ASSAY
Bio-Rad
LSR
Apr 12, 2007K062473LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
DiaSorin, Inc.
LSR
Aug 11, 2005K051169BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
Viramed Biotech AG
LSR
Aug 11, 2005K051071VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
Viramed Biotech AG
LSR
Nov 26, 2003K033083BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
Trinity Biotech USA
LSR
Nov 26, 2003K033070BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
Trinity Biotech USA
LSR
Nov 24, 2003K032713BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
Boston Biomedica, Inc.
LSR
May 10, 2001K003754IMMUNETICS C6 LYME ELISA KIT
Immunetics, Inc.
LSR
Jan 27, 2000K994004QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
Inova Diagnostics, Inc.
LSR
Sep 21, 1999K991063QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
Immunetics, Inc.
LSR
Sep 21, 1999K991062QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
Immunetics, Inc.
LSR

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