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 Medical Diagnostic Technologies, Inc..

112
Total
112
Cleared
177d
Avg days
1987
Since
112 devices
49–72 of 112
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 Aug 25, 1987
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246
Zeus Scientific, Inc.
Microbiology · 151d