Multiple infectious organism IVDs

Intended purpose

The product STI PLUS ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used b as qualitative multiplex nucleic acids Real-Time PCR assay for the detection and identification of the DNA of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis extracted from clinical specimens. The product is intended for use as an aid in the diagnosis of urogenital tract infections in patients suspected of having Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium or Trichomonas vaginalis infections.