Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Elitechgroup). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT774 - Multiple-bacteria IVDs
Intended purpose
The product UroGen ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used as a qualitative multiplex nucleic acids Real-Time PCR assay for the detection and identification of the genomic DNA of Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum, 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 Mycoplasma hominis, Ureaplasma urealyticum or Ureaplasma parvum infection.