Product code LSR— Microbiology
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- Classification name
- Reagent, Borrelia Serological Reagent
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Total cleared
- 112
- First cleared
- Most recent
Market context for product code LSR
FDA has cleared devices under product code LSR between 1987 and 2026, filed by 42 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2013
- 2012
- 2010
Top applicants under product code LSR
Recent clearances under product code LSR
1–100 of 112- K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- K252627 — Lyme-ID IgG Test; Bio-ID800
- K242872 — iDart Lyme IgM ImmunoBlot Kit
- K233367 — iDart Lyme IgG ImmunoBlot Kit
- K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
- K220016 — Viramed Borrela All-In-One ViraChip Test Kit
- K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
- K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
- K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
- K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K200025 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K193051 — LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
- K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K183446 — BioPlex 2200 Lyme Total
- K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set
- K180264 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
- K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
- K172254 — Lyme B. burgdorferi (IgM) MarStripe Test
- K163713 — Sofia Lyme FIA, Sofia Lyme Control Set
- K163695 — Borrelia B31 ViraChip IgM Test Kit
- K163504 — Borrelia B31 ViraChip IgG Test Kit
- K163095 — Lyme B. burgdorferi (IgG) MarStripe Test
- K161513 — Anti-Borrelia burgdorferi US Westernblot (IgG)
- K142038 — EUROIMMUN LYME ELISA(IgG/IgM)
- K122979 — VIDAS LYME IGM
- K122986 — VIDAS LYME IGG
- K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
- K113846 — BORRELIA BURGDORFERI IGM BLOT TEST
- K113847 — BORRELIA BURGDORFERI IGG BLOT TEST
- K100728 — ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
- K092693 — VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
- K082329 — VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
- K081362 — PLATELIA LYME IGM
- K080012 — PLATELIA LYME IGG ASSAY
- K062473 — LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
- K051071 — VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
- K051169 — BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
- K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K032713 — BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
- K003754 — IMMUNETICS C6 LYME ELISA KIT
- K994004 — QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
- K991062 — QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
- K991063 — QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
- K991180 — BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
- K991185 — BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
- K984222 — QUANTA LITE LYME IGG ELISA
- K984234 — QUANTA LITE LYME IGM ELISA
- K984138 — APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
- K980351 — BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
- K981913 — PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
- K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM
- K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
- K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
- K970761 — LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
- K970768 — HUMAN LYME IGM WESTERN BLOT KIT
- K971169 — CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
- K971170 — CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
- K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
- K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
- K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K951709 — MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
- K950829 — MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
- K953682 — IMMUNO DOT BORRELIA DOT BLOT G TEST
- K953683 — MMUNO DOT BORRELIA DOT BLOT M TEST
- K943812 — VIDAS LYME SCREEN II
- K922578 — BARTELS LYME DISEASE IGM EIA
- K911627 — IMMUNODOT BORRELIA (LYME) TEST
- K911599 — IMMUNOWELL LYME (P39 RECOMBINANT) TEST
- K911590 — IMMUNOWELL BORRELIA (LYME)TEST
- K896378 — LYME-CHECK(TM) TEST KIT
- K904652 — LYME STAT M TEST KIT
- K904893 — FIAX LYME M TEST KIT
- K910230 — LYME-SPOT IF KIT
- K900206 — LYME DISEASE IGM ELISA
- K911496 — FASTTECH SYSTEM 1
- K903013 — LYME IGM ELISA TEST
- K910899 — LYME DISEASE MICROASSAY
- K911330 — LYME IGM MICROASSAY
- K911145 — BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
- K895713 — 3M IGG FASTLYME(TM) TEST
- K900196 — LYME IGM ELISA TEST SYSTEM
- K900572 — LYME IGM MICROASSAY
- K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
- K895292 — LYME IGG ELISA TEST SYSTEM
- K894410 — IMMUNODOT LYME TEST
- K894609 — MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
- K894224 — MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
- K894293 — MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
- K892206 — MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
- K890843 — LYME DISEASE MICROASSAY
- K890053 — MARDX LYME DISEASE IGG IFA TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.