CT923 - Multiple infectious organism IVDs

Multiple infectious organism in vitro diagnostic devices are intended to be used in testing to provide information about mixed infection with or exposure to multiple specified infectious organisms from different microbial groups, which may include viruses, bacteria, fungi, parasites and/or prions. These devices are employed in clinical contexts including detection of sexually transmitted infections and genital tract infections, diagnosis of conditions such as candidiasis, trichomoniasis and bacterial vaginosis, and assessment of herpes simplex virus and other pathogenic organisms in anogenital, oral and urogenital specimens from patients with suspected infections.