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 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 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 Oct 30, 1989
IMMUNODOT LYME TEST
K894410
General Biometrics, Inc.
Microbiology · 105d
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
Cleared Mar 15, 1989
LYME DISEASE IFA (IGM)
K883767
Hillcrest Biologicals
Microbiology · 190d
Cleared Mar 02, 1989
LYME ELISA TEST SYSTEM
K885317
Zeus Scientific, Inc.
Microbiology · 62d
Cleared Jan 13, 1989
LYME FAST TEST
K883544
3M Company
Microbiology · 147d
Cleared Dec 13, 1988
LYME DISEASE IFA (IGG)
K883487
Hillcrest Biologicals
Microbiology · 119d
Cleared Apr 26, 1988
LYME DISEASE ELISA
K880476
Hillcrest Biologicals
Microbiology · 82d
Cleared Mar 30, 1988
LYME STAT TEST KIT
K875286
Whittaker Bioproducts, Inc.
Microbiology · 92d