Dna-Reagents, Legionella

FDA product code LQH · Class II (moderate risk) · 21 CFR 866.3300 · Microbiology

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K033861BD Probetec Et Legionella Pneumophila (LP) Amplified DNA AssayLQH · Traditional Becton, Dickinson & CO03/09/2004SE
K860498Gen-Probe Legionella Rapid Diagnostic SystemLQH · Traditional Gen-Probe, Inc.07/16/1986SE