LSR · Class II · 21 CFR 866.3830

FDA Product Code LSR: Reagent, Borrelia Serological Reagent

Leading manufacturers include Zeus Scientific, Inc., Gold Standard Diagnostics and Viramed Biotech AG.

112
Total
112
Cleared
177d
Avg days
1987
Since
112 devices
25–48 of 112
Cleared Oct 20, 2017
Sofia Lyme FIA, Sofia Lyme Control Set
K163713
Quidel Corporation
Microbiology · 294d
Cleared Aug 22, 2017
Borrelia B31 ViraChip IgM Test Kit
K163695
Viramed Biotech AG
Microbiology · 237d
Cleared Jul 12, 2017
Borrelia B31 ViraChip IgG Test Kit
K163504
Viramed Biotech AG
Microbiology · 210d
Cleared Feb 01, 2017
Lyme B. burgdorferi (IgG) MarStripe Test
K163095
Trinity Biotech
Microbiology · 89d
Cleared Aug 25, 2016
Anti-Borrelia burgdorferi US Westernblot (IgG)
K161513
Euroimmun US
Microbiology · 84d
Cleared May 04, 2015
EUROIMMUN LYME ELISA(IgG/IgM)
K142038
Euroimmun US
Microbiology · 280d
Cleared Jun 04, 2013
VIDAS LYME IGM
K122979
Biomerieux S.A.
Microbiology · 251d
Cleared Mar 05, 2013
VIDAS LYME IGG
K122986
Biomerieux S.A.
Microbiology · 160d
Cleared Jul 26, 2012
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
K113846
Gold Standard Diagnostics
Microbiology · 155d
Cleared Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
K113847
Gold Standard Diagnostics
Microbiology · 104d
Cleared Jul 06, 2010
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
K100728
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Nov 25, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
K092693
Viramed Biotech AG
Microbiology · 84d
Cleared Aug 05, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
K082329
Viramed Biotech AG
Microbiology · 356d
Cleared Jun 26, 2008
PLATELIA LYME IGM
K081362
Bio-Rad
Microbiology · 42d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012
Bio-Rad
Microbiology · 126d
Cleared Apr 12, 2007
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473
DiaSorin, Inc.
Microbiology · 231d
Cleared Aug 11, 2005
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
K051071
Viramed Biotech AG
Microbiology · 107d
Cleared Aug 11, 2005
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
K051169
Viramed Biotech AG
Microbiology · 104d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K033070
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K033083
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 24, 2003
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
K032713
Boston Biomedica, Inc.
Microbiology · 83d
Cleared May 10, 2001
IMMUNETICS C6 LYME ELISA KIT
K003754
Immunetics, Inc.
Microbiology · 156d
Cleared Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004
Inova Diagnostics, Inc.
Microbiology · 64d