MJM — Dna Probe, Gardnerella Vaginalis Class I

FDA Device Classification

FDA product code MJM covers "Dna Probe, Gardnerella Vaginalis", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.