Antisera, Fluorescent, All Groups, N. Meningitidis

FDA product code GTI · Class II (moderate risk) · 21 CFR 866.3390 · Microbiology

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K920274Directigen Neisseria Meningitidis TestGTI · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic03/18/1992SE
K841308Directigen Menningitis Test KitGTI · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic05/02/1984SE