Details
Device typeMultiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).
FDA categoryNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
Device ID00875197006056
Catalog number08017450190
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information