FDA Product Code
FDA Product Code LSR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3830
510(k) Clearances — 112 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026-07-10 | Traditional | PDF ↗ |
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | 2025-11-14 | Traditional | PDF ↗ |
| K242872 | iDart Lyme IgM ImmunoBlot Kit | Id-Fish Technology, Inc. | 2025-06-12 | Traditional | PDF ↗ |
| K233367 | iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. | 2024-08-12 | Traditional | PDF ↗ |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific | 2023-07-13 | Traditional | PDF ↗ |
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | 2022-08-19 | Traditional | PDF ↗ |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 | Traditional | PDF ↗ |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 | Traditional | PDF ↗ |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 | Traditional | PDF ↗ |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 | Traditional | PDF ↗ |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021-02-18 | Traditional | PDF ↗ |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021-02-18 | Traditional | PDF ↗ |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2020-04-06 | Traditional | PDF ↗ |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2020-04-06 | Traditional | PDF ↗ |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | 2020-01-29 | Traditional | PDF ↗ |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Zeus Scientific, Inc. | 2019-07-29 | Traditional | PDF ↗ |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Zeus Scientific, Inc. | 2019-07-29 | Traditional | PDF ↗ |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Zeus Scientific, Inc. | 2019-07-29 | Traditional | PDF ↗ |
| K183446 | BioPlex 2200 Lyme Total | Bio-Rad Laboratories | 2019-03-12 | Traditional | PDF ↗ |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2018-08-30 | Dual Track | PDF ↗ |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2018-05-02 | Traditional | PDF ↗ |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Quidel Corporation | 2018-02-28 | Traditional | PDF ↗ |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | Euroimmun Us, Inc. | 2017-12-10 | Traditional | PDF ↗ |
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | Trinity Biotech | 2017-10-23 | Traditional | PDF ↗ |
| K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2017-10-20 | Traditional | PDF ↗ |
| K163695 | Borrelia B31 ViraChip IgM Test Kit | Viramed Biotech AG | 2017-08-22 | Traditional | PDF ↗ |
| K163504 | Borrelia B31 ViraChip IgG Test Kit | Viramed Biotech AG | 2017-07-12 | Traditional | PDF ↗ |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | Trinity Biotech | 2017-02-01 | Traditional | PDF ↗ |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | Euroimmun US | 2016-08-25 | Traditional | PDF ↗ |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | Euroimmun US | 2015-05-04 | Traditional | PDF ↗ |
| K122979 | VIDAS LYME IGM | Biomerieux S.A. | 2013-06-04 | Traditional | PDF ↗ |
| K122986 | VIDAS LYME IGG | Biomerieux S.A. | 2013-03-05 | Traditional | PDF ↗ |
| K113397 | ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM | Zeus Scientific, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K113846 | BORRELIA BURGDORFERI IGM BLOT TEST | Gold Standard Diagnostics | 2012-06-01 | Traditional | PDF ↗ |
| K113847 | BORRELIA BURGDORFERI IGG BLOT TEST | Gold Standard Diagnostics | 2012-04-11 | Traditional | PDF ↗ |
| K100728 | ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM | Zeus Scientific, Inc. | 2010-07-06 | Traditional | PDF ↗ |
| K092693 | VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS | Viramed Biotech AG | 2009-11-25 | Traditional | PDF ↗ |
| K082329 | VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE | Viramed Biotech AG | 2009-08-05 | Traditional | PDF ↗ |
| K081362 | PLATELIA LYME IGM | Bio-Rad | 2008-06-26 | Traditional | PDF ↗ |
| K080012 | PLATELIA LYME IGG ASSAY | Bio-Rad | 2008-05-08 | Traditional | PDF ↗ |
| K062473 | LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 | DiaSorin, Inc. | 2007-04-12 | Traditional | PDF ↗ |
| K051169 | BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT | Viramed Biotech AG | 2005-08-11 | Traditional | PDF ↗ |
| K051071 | VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT | Viramed Biotech AG | 2005-08-11 | Traditional | PDF ↗ |
| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Trinity Biotech USA | 2003-11-26 | Traditional | PDF ↗ |
| K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Trinity Biotech USA | 2003-11-26 | Traditional | PDF ↗ |
| K032713 | BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG | Boston Biomedica, Inc. | 2003-11-24 | Traditional | PDF ↗ |
| K003754 | IMMUNETICS C6 LYME ELISA KIT | Immunetics, Inc. | 2001-05-10 | Traditional | PDF ↗ |
| K994004 | QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT | Inova Diagnostics, Inc. | 2000-01-27 | Traditional | PDF ↗ |
| K991063 | QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 | Immunetics, Inc. | 1999-09-21 | Traditional | PDF ↗ |
| K991062 | QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 | Immunetics, Inc. | 1999-09-21 | Traditional | PDF ↗ |
| K991185 | BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM | Zeus Scientific, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K991180 | BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM | Zeus Scientific, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K984234 | QUANTA LITE LYME IGM ELISA | Inova Diagnostics, Inc. | 1999-04-15 | Traditional | PDF ↗ |
| K984222 | QUANTA LITE LYME IGG ELISA | Inova Diagnostics, Inc. | 1999-04-15 | Traditional | PDF ↗ |
| K984138 | APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-23 | Traditional | PDF ↗ |
| K980351 | BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT | Boston Biomedica, Inc. | 1999-03-05 | Traditional | PDF ↗ |
| K981913 | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY | Chembio Diagnostic Systems, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K983606 | IS BORRELIA BURGDORFERI IGM TEST SYSTEM | Columbia Bioscience, Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K983605 | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K971006 | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) | Mrl Diagnostics | 1998-06-01 | Traditional | PDF ↗ |
| K971007 | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) | Mrl Diagnostics | 1998-06-01 | Traditional | PDF ↗ |
| K970768 | HUMAN LYME IGM WESTERN BLOT KIT | Cambridge Diagnostics Ireland, Ltd. | 1998-04-09 | Traditional | PDF ↗ |
| K970761 | LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) | Cambridge Diagnostics Ireland, Ltd. | 1998-04-09 | Traditional | PDF ↗ |
| K971170 | CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) | Cambridge Biotech Corp. | 1998-02-17 | Traditional | PDF ↗ |
| K971169 | CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) | Cambridge Biotech Corp. | 1998-02-17 | Traditional | PDF ↗ |
| K974809 | ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1998-02-05 | Traditional | PDF ↗ |
| K974810 | ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL | Boston Biomedica, Inc. | 1998-02-05 | Traditional | PDF ↗ |
| K965131 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Wampole Laboratories | 1997-03-26 | Traditional | PDF ↗ |
| K965129 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Wampole Laboratories | 1997-03-26 | Traditional | PDF ↗ |
| K951709 | MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM | Mardx Diagnostics, Inc. | 1996-06-07 | Traditional | PDF ↗ |
| K950829 | MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM | Mardx Diagnostics, Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K953682 | IMMUNO DOT BORRELIA DOT BLOT G TEST | Genbio | 1996-05-03 | Traditional | PDF ↗ |
| K953683 | MMUNO DOT BORRELIA DOT BLOT M TEST | Genbio | 1996-05-03 | Traditional | PDF ↗ |
| K943812 | VIDAS LYME SCREEN II | Biomerieux Vitek, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K922578 | BARTELS LYME DISEASE IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 | Traditional | PDF ↗ |
| K911627 | IMMUNODOT BORRELIA (LYME) TEST | General Biometrics, Inc. | 1992-04-08 | Traditional | PDF ↗ |
| K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST | General Biometrics, Inc. | 1991-12-30 | Traditional | PDF ↗ |
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST | General Biometrics, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K896378 | LYME-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K904652 | LYME STAT M TEST KIT | Whittaker Bioproducts, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K904893 | FIAX LYME M TEST KIT | Whittaker Bioproducts, Inc. | 1991-10-16 | Traditional | PDF ↗ |
| K910230 | LYME-SPOT IF KIT | Vitek Systems, Inc. | 1991-08-30 | Traditional | PDF ↗ |
| K900206 | LYME DISEASE IGM ELISA | Hillcrest Biologicals | 1991-06-28 | Traditional | PDF ↗ |
| K911496 | FASTTECH SYSTEM 1 | 3M Diagnostic Systems, Inc. | 1991-06-24 | Traditional | PDF ↗ |
| K903013 | LYME IGM ELISA TEST | Gull Laboratories, Inc. | 1991-06-21 | Traditional | PDF ↗ |
| K910899 | LYME DISEASE MICROASSAY | Diamedix Corp. | 1991-06-10 | Traditional | PDF ↗ |
| K911330 | LYME IGM MICROASSAY | Diamedix Corp. | 1991-06-10 | Traditional | PDF ↗ |
| K911145 | BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST | Medical Diagnostic Technologies, Inc. | 1991-05-10 | Traditional | PDF ↗ |
| K895713 | 3M IGG FASTLYME(TM) TEST | 3M Company | 1990-12-14 | Traditional | PDF ↗ |
| K900572 | LYME IGM MICROASSAY | Diamedix Corp. | 1990-05-02 | Traditional | PDF ↗ |
| K900196 | LYME IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1990-05-02 | Traditional | PDF ↗ |
| K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | Bion Ent., Ltd. | 1990-04-05 | Traditional | PDF ↗ |
| K895292 | LYME IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K894410 | IMMUNODOT LYME TEST | General Biometrics, Inc. | 1989-10-30 | Traditional | PDF ↗ |
| K894609 | MARDX LYME DISEASE IFA (IGM) TEST SYSTEM | Mardx, Inc. | 1989-09-19 | Traditional | PDF ↗ |
| K894293 | MARDX LYME DISEASE EIA (IGM) TEST SYSTEM | Mardx Diagnostics, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K894224 | MARDX LYME DISEASE EIA (IGG) TEST SYSTEM | Mardx Diagnostics, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K892206 | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM | Mardx Diagnostics, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K890843 | LYME DISEASE MICROASSAY | Diamedix Corp. | 1989-07-25 | Traditional | PDF ↗ |
| K890053 | MARDX LYME DISEASE IGG IFA TEST SYSTEM | Mardx Diagnostics, Inc. | 1989-04-18 | Traditional | PDF ↗ |
Product code LSR · Class II · Microbiology. Data: openFDA.