510(k) clearances for Reagent, Borrelia Serological Reagent
112 on file
- Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)Jul 10, 2026
K254295 · Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- Inanovate, Inc.Nov 14, 2025
K252627 · Lyme-ID IgG Test; Bio-ID800
- Id-Fish Technology, Inc.Jun 12, 2025
K242872 · iDart Lyme IgM ImmunoBlot Kit
- Id-Fish Technology, Inc.Aug 12, 2024
K233367 · iDart Lyme IgG ImmunoBlot Kit
- Zeus ScientificJul 13, 2023
K230863 · ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
- Viramed Biotech AGAug 19, 2022
K220016 · Viramed Borrela All-In-One ViraChip Test Kit
- Gold Standard DiagnosticsMar 22, 2021
K203295 · Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- Gold Standard DiagnosticsMar 22, 2021
K203292 · Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- Gold Standard DiagnosticsMar 22, 2021
K203296 · Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- Gold Standard DiagnosticsMar 22, 2021
K203289 · Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
- DiaSorin, Inc.Feb 18, 2021
K202573 · LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
- DiaSorin, Inc.Feb 18, 2021
K202574 · LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
- Gold Standard DiagnosticsApr 6, 2020
K200023 · Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- Gold Standard DiagnosticsApr 6, 2020
K200025 · Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- DiaSorin, Inc.Jan 29, 2020
K193051 · LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
- Zeus Scientific, Inc.Jul 29, 2019
K190907 · ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- Zeus Scientific, Inc.Jul 29, 2019
K191398 · ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- Zeus Scientific, Inc.Jul 29, 2019
K191240 · ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- Bio-Rad LaboratoriesMar 12, 2019
K183446 · BioPlex 2200 Lyme Total
- Quidel CorporationAug 30, 2018
K173496 · Sofia 2 Lyme FIA, Sofia Lyme Control Set
- Gold Standard DiagnosticsMay 2, 2018
K180264 · Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- Quidel CorporationFeb 28, 2018
K173691 · Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
- Euroimmun Us, Inc.Dec 10, 2017
K172722 · Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
- Trinity BiotechOct 23, 2017
K172254 · Lyme B. burgdorferi (IgM) MarStripe Test
- Quidel CorporationOct 20, 2017
K163713 · Sofia Lyme FIA, Sofia Lyme Control Set
- Viramed Biotech AGAug 22, 2017
K163695 · Borrelia B31 ViraChip IgM Test Kit
- Viramed Biotech AGJul 12, 2017
K163504 · Borrelia B31 ViraChip IgG Test Kit
- Trinity BiotechFeb 1, 2017
K163095 · Lyme B. burgdorferi (IgG) MarStripe Test
- Euroimmun USAug 25, 2016
K161513 · Anti-Borrelia burgdorferi US Westernblot (IgG)
- Euroimmun USMay 4, 2015
K142038 · EUROIMMUN LYME ELISA(IgG/IgM)
- Biomerieux S.A.Jun 4, 2013
K122979 · VIDAS LYME IGM
- Biomerieux S.A.Mar 5, 2013
K122986 · VIDAS LYME IGG
- Zeus Scientific, Inc.Jul 26, 2012
K113397 · ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
- Gold Standard DiagnosticsJun 1, 2012
K113846 · BORRELIA BURGDORFERI IGM BLOT TEST
- Gold Standard DiagnosticsApr 11, 2012
K113847 · BORRELIA BURGDORFERI IGG BLOT TEST
- Zeus Scientific, Inc.Jul 6, 2010
K100728 · ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
- Viramed Biotech AGNov 25, 2009
K092693 · VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
- Viramed Biotech AGAug 5, 2009
K082329 · VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
- Bio-RadJun 26, 2008
K081362 · PLATELIA LYME IGM
- Bio-RadMay 8, 2008
K080012 · PLATELIA LYME IGG ASSAY
- DiaSorin, Inc.Apr 12, 2007
K062473 · LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
- Viramed Biotech AGAug 11, 2005
K051071 · VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
- Viramed Biotech AGAug 11, 2005
K051169 · BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
- Trinity Biotech USANov 26, 2003
K033070 · BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- Trinity Biotech USANov 26, 2003
K033083 · BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- Boston Biomedica, Inc.Nov 24, 2003
K032713 · BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
- Immunetics, Inc.May 10, 2001
K003754 · IMMUNETICS C6 LYME ELISA KIT
- Inova Diagnostics, Inc.Jan 27, 2000
K994004 · QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
- Immunetics, Inc.Sep 21, 1999
K991062 · QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
- Immunetics, Inc.Sep 21, 1999
K991063 · QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
- Zeus Scientific, Inc.Sep 3, 1999
K991185 · BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
- Zeus Scientific, Inc.Sep 3, 1999
K991180 · BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
- Inova Diagnostics, Inc.Apr 15, 1999
K984222 · QUANTA LITE LYME IGG ELISA
- Inova Diagnostics, Inc.Apr 15, 1999
K984234 · QUANTA LITE LYME IGM ELISA
- Zeus Scientific, Inc.Mar 23, 1999
K984138 · APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
- Boston Biomedica, Inc.Mar 5, 1999
K980351 · BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
- Chembio Diagnostic Systems, Inc.Feb 12, 1999
K981913 · PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
- Columbia Bioscience, Inc.Dec 16, 1998
K983606 · IS BORRELIA BURGDORFERI IGM TEST SYSTEM
- Columbia Bioscience, Inc.Dec 16, 1998
K983605 · IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- Mrl DiagnosticsJun 1, 1998
K971007 · LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
- Mrl DiagnosticsJun 1, 1998
K971006 · LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
- Cambridge Diagnostics Ireland, Ltd.Apr 9, 1998
K970761 · LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
- Cambridge Diagnostics Ireland, Ltd.Apr 9, 1998
K970768 · HUMAN LYME IGM WESTERN BLOT KIT
- Cambridge Biotech Corp.Feb 17, 1998
K971169 · CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
- Cambridge Biotech Corp.Feb 17, 1998
K971170 · CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
- Boston Biomedica, Inc.Feb 5, 1998
K974810 · ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
- Boston Biomedica, Inc.Feb 5, 1998
K974809 · ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
- Wampole LaboratoriesMar 26, 1997
K965131 · BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- Wampole LaboratoriesMar 26, 1997
K965129 · BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- Mardx Diagnostics, Inc.Jun 7, 1996
K951709 · MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
- Mardx Diagnostics, Inc.Jun 5, 1996
K950829 · MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
- GenbioMay 3, 1996
K953682 · IMMUNO DOT BORRELIA DOT BLOT G TEST
- GenbioMay 3, 1996
K953683 · MMUNO DOT BORRELIA DOT BLOT M TEST
- Biomerieux Vitek, Inc.Jun 13, 1995
K943812 · VIDAS LYME SCREEN II
- Baxter Diagnostics, Inc.Sep 2, 1992
K922578 · BARTELS LYME DISEASE IGM EIA
- General Biometrics, Inc.Apr 8, 1992
K911627 · IMMUNODOT BORRELIA (LYME) TEST
- General Biometrics, Inc.Dec 30, 1991
K911599 · IMMUNOWELL LYME (P39 RECOMBINANT) TEST
- General Biometrics, Inc.Dec 20, 1991
K911590 · IMMUNOWELL BORRELIA (LYME)TEST
- Diagnostic Technology, Inc.Nov 5, 1991
K896378 · LYME-CHECK(TM) TEST KIT
- Whittaker Bioproducts, Inc.Oct 21, 1991
K904652 · LYME STAT M TEST KIT
- Whittaker Bioproducts, Inc.Oct 16, 1991
K904893 · FIAX LYME M TEST KIT
- Vitek Systems, Inc.Aug 30, 1991
K910230 · LYME-SPOT IF KIT
- Hillcrest BiologicalsJun 28, 1991
K900206 · LYME DISEASE IGM ELISA
- 3M Diagnostic Systems, Inc.Jun 24, 1991
K911496 · FASTTECH SYSTEM 1
- Gull Laboratories, Inc.Jun 21, 1991
K903013 · LYME IGM ELISA TEST
- Diamedix Corp.Jun 10, 1991
K911330 · LYME IGM MICROASSAY
- Diamedix Corp.Jun 10, 1991
K910899 · LYME DISEASE MICROASSAY
- Medical Diagnostic Technologies, Inc.May 10, 1991
K911145 · BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
- 3M CompanyDec 14, 1990
K895713 · 3M IGG FASTLYME(TM) TEST
- Diamedix Corp.May 2, 1990
K900572 · LYME IGM MICROASSAY
- Zeus Scientific, Inc.May 2, 1990
K900196 · LYME IGM ELISA TEST SYSTEM
- Bion Ent., Ltd.Apr 5, 1990
K901054 · BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
- Zeus Scientific, Inc.Dec 13, 1989
K895292 · LYME IGG ELISA TEST SYSTEM
- General Biometrics, Inc.Oct 30, 1989
K894410 · IMMUNODOT LYME TEST
- Mardx, Inc.Sep 19, 1989
K894609 · MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
- Mardx Diagnostics, Inc.Aug 21, 1989
K894293 · MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
- Mardx Diagnostics, Inc.Aug 21, 1989
K894224 · MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
- Mardx Diagnostics, Inc.Aug 15, 1989
K892206 · MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
- Diamedix Corp.Jul 25, 1989
K890843 · LYME DISEASE MICROASSAY
- Mardx Diagnostics, Inc.Apr 18, 1989
K890053 · MARDX LYME DISEASE IGG IFA TEST SYSTEM
- Medical Diagnostic Technologies, Inc.Apr 10, 1989
K885293 · BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
- Medical Diagnostic Technologies, Inc.Apr 10, 1989
K885294 · BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
- Medical Diagnostic Technologies, Inc.Apr 10, 1989
K885290 · BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
- Cambridge Bioscience Corp.Mar 15, 1989
K890281 · HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
- Hillcrest BiologicalsMar 15, 1989
K883767 · LYME DISEASE IFA (IGM)
- Zeus Scientific, Inc.Mar 2, 1989
K885317 · LYME ELISA TEST SYSTEM
- 3M CompanyJan 13, 1989
K883544 · LYME FAST TEST
- Hillcrest BiologicalsDec 13, 1988
K883487 · LYME DISEASE IFA (IGG)
- Hillcrest BiologicalsApr 26, 1988
K880476 · LYME DISEASE ELISA
- Whittaker Bioproducts, Inc.Mar 30, 1988
K875286 · LYME STAT TEST KIT
- Whittaker Bioproducts, Inc.Oct 15, 1987
K872247 · FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
- Zeus Scientific, Inc.Aug 25, 1987
K871246 · IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI