Product code LSR— Microbiology
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- Advisory panel
- Microbiology
- Total cleared
- 112
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.