Device Dossier

Multiple infectious organism IVDs

Device Dossier for Multiple infectious organism IVDs (CT923 - Multiple infectious organism IVDs, Class 3, sponsor Abacus dx). ARTG record, intended…

Intended purpose

IVDs to detect suspected infectious diseases including RT-PCR kit to detect nucleic acid from Chlamydia trachomatis serovar L (CT-LGV), Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), Treponema pallidum (TP), Haemophilus ducreyi (HD), Varicella zoster virus (VZV) and Monkeypox virus (MPXV) in genital skin lesions and perianal/rectal exudates.

TGA Public Summary