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 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