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
97–112 of 112
Cleared Aug 21, 1989
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
K894293
Mardx Diagnostics, Inc.
Microbiology · 59d
Cleared Aug 15, 1989
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
K892206
Mardx Diagnostics, Inc.
Microbiology · 134d
Cleared Jul 25, 1989
LYME DISEASE MICROASSAY
K890843
Diamedix Corp.
Microbiology · 154d
Cleared Apr 18, 1989
MARDX LYME DISEASE IGG IFA TEST SYSTEM
K890053
Mardx Diagnostics, Inc.
Microbiology · 102d
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 15, 1989
HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
K890281
Cambridge Bioscience Corp.
Microbiology · 57d
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
Cleared Oct 15, 1987
FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
K872247
Whittaker Bioproducts, Inc.
Microbiology · 126d
Cleared Aug 25, 1987
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246
Zeus Scientific, Inc.
Microbiology · 151d