Dna Probe, Gardnerella Vaginalis

FDA product code MJM · Class I (low risk) · 21 CFR 866.2660 · Microbiology

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K964015Indicard TestMJM · Traditional Litmus Concepts, Inc.06/19/1997SE
K923133Affirm/Vp Ident.Test G.Vaginalis & T.VaginalisMJM · Traditional Microprobe Corp.09/25/1992SE