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
73–96 of 112
Cleared May 03, 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683
Genbio
Microbiology · 270d
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 Apr 08, 1992
IMMUNODOT BORRELIA (LYME) TEST
K911627
General Biometrics, Inc.
Microbiology · 363d
Cleared Dec 30, 1991
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599
General Biometrics, Inc.
Microbiology · 265d
Cleared Dec 20, 1991
IMMUNOWELL BORRELIA (LYME)TEST
K911590
General Biometrics, Inc.
Microbiology · 255d
Cleared Nov 05, 1991
LYME-CHECK(TM) TEST KIT
K896378
Diagnostic Technology, Inc.
Microbiology · 729d
Cleared Oct 21, 1991
LYME STAT M TEST KIT
K904652
Whittaker Bioproducts, Inc.
Microbiology · 371d
Cleared Oct 16, 1991
FIAX LYME M TEST KIT
K904893
Whittaker Bioproducts, Inc.
Microbiology · 351d
Cleared Aug 30, 1991
LYME-SPOT IF KIT
K910230
Vitek Systems, Inc.
Microbiology · 224d
Cleared Jun 28, 1991
LYME DISEASE IGM ELISA
K900206
Hillcrest Biologicals
Microbiology · 528d
Cleared Jun 24, 1991
FASTTECH SYSTEM 1
K911496
3M Diagnostic Systems, Inc.
Microbiology · 81d
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 Apr 05, 1990
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
K901054
Bion Ent., Ltd.
Microbiology · 30d
Cleared Dec 13, 1989
LYME IGG ELISA TEST SYSTEM
K895292
Zeus Scientific, Inc.
Microbiology · 110d
Cleared Oct 30, 1989
IMMUNODOT LYME TEST
K894410
General Biometrics, Inc.
Microbiology · 105d
Cleared Sep 19, 1989
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
K894609
Mardx, Inc.
Microbiology · 61d
Cleared Aug 21, 1989
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
K894224
Mardx Diagnostics, Inc.
Microbiology · 63d