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
49–72 of 112
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
K991062
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
K991063
Immunetics, Inc.
Microbiology · 174d
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 Mar 05, 1999
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K980351
Boston Biomedica, Inc.
Microbiology · 400d
Cleared Feb 12, 1999
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
K981913
Chembio Diagnostic Systems, Inc.
Microbiology · 256d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K983605
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGM TEST SYSTEM
K983606
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
K971006
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
K971007
Mrl Diagnostics
Microbiology · 439d
Cleared Apr 09, 1998
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
K970761
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
HUMAN LYME IGM WESTERN BLOT KIT
K970768
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K965129
Wampole Laboratories
Microbiology · 93d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K965131
Wampole Laboratories
Microbiology · 93d
Cleared Jun 07, 1996
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
K951709
Mardx Diagnostics, Inc.
Microbiology · 421d
Cleared Jun 05, 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
K950829
Mardx Diagnostics, Inc.
Microbiology · 468d
Cleared May 03, 1996
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682
Genbio
Microbiology · 270d