QEP
Alinity m STI Assay
- Advisory panel
- Microbiology
- Total cleared
- 21
Recent clearances under product code QEP
- K251501 — Visby Medical Men's Sexual Health Test
- K243343 — BD CTGCTV2
- K240217 — cobas® liat CT/NG nucleic acid test
- K240197 — cobas® liat CT/NG/MG nucleic acid test
- K230267 — NeuMoDx CT/NG Assay 2.0
- K220407 — Visby Medical Sexual Health Test
- K222379 — Alinity m STI Assay
- K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
- K210585 — BD CTGCTV2
- K202977 — Alinity m STI Assay
- K193081 — Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
- K200748 — Visby Medical Sexual Health
- K202408 — cobas CTNG for use on cobas 6800/8800 systems
- K200866 — Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
- K200533 — binx io CT/NG Assay and binx io CT/NG System
- K200436 — Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
- K191352 — binx health io CT/NG Assay
- K190441 — Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
- K190515 — Aptima Combo 2 Assay (Panther System)
- K190433 — cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
- DEN180047 — Aptima Mycoplasma genitalium Assay
Data sourced from openFDA. This site is unofficial and independent of the FDA.