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 Medical Diagnostic Technologies, Inc..

112
Total
112
Cleared
177d
Avg days
1987
Since
112 devices
25–48 of 112
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 Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004
Inova Diagnostics, Inc.
Microbiology · 64d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Apr 15, 1999
QUANTA LITE LYME IGG ELISA
K984222
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 15, 1999
QUANTA LITE LYME IGM ELISA
K984234
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Mar 23, 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138
Zeus Scientific, Inc.
Microbiology · 125d
Cleared Jun 13, 1995
VIDAS LYME SCREEN II
K943812
Biomerieux Vitek, Inc.
Microbiology · 312d
Cleared Sep 02, 1992
BARTELS LYME DISEASE IGM EIA
K922578
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Aug 30, 1991
LYME-SPOT IF KIT
K910230
Vitek Systems, Inc.
Microbiology · 224d
Cleared Jun 21, 1991
LYME IGM ELISA TEST
K903013
Gull Laboratories, Inc.
Microbiology · 345d
Cleared Jun 10, 1991
LYME DISEASE MICROASSAY
K910899
Diamedix Corp.
Microbiology · 105d
Cleared Jun 10, 1991
LYME IGM MICROASSAY
K911330
Diamedix Corp.
Microbiology · 77d
Cleared May 10, 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145
Medical Diagnostic Technologies, Inc.
Microbiology · 70d
Cleared Dec 14, 1990
3M IGG FASTLYME(TM) TEST
K895713
3M Company
Microbiology · 445d
Cleared May 02, 1990
LYME IGM ELISA TEST SYSTEM
K900196
Zeus Scientific, Inc.
Microbiology · 106d
Cleared May 02, 1990
LYME IGM MICROASSAY
K900572
Diamedix Corp.
Microbiology · 84d
Cleared Dec 13, 1989
LYME IGG ELISA TEST SYSTEM
K895292
Zeus Scientific, Inc.
Microbiology · 110d
Cleared Jul 25, 1989
LYME DISEASE MICROASSAY
K890843
Diamedix Corp.
Microbiology · 154d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294
Medical Diagnostic Technologies, Inc.
Microbiology · 104d