Aptima Mycoplasma genitalium Assay

DEN180047 is the FDA 510(k) clearance record for Aptima Mycoplasma genitalium Assay, a class II device, cleared for Hologic, Inc. on 2019-01-23 under FDA product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections). FDA's definition for product code QEP reads: "A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in...". FDA records list 189 510(k) clearances for Hologic, Inc., from 1985-07-08 to 2026-08-12. As of 2026-09-10, FDA records show no recalls naming DEN180047.