Device typeSexually transmitted infection (STI) testing specimen collection kit IVD, clinical: A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.
FDA categoryVaginitis and bacterial vaginosis nucleic acid detection system
Device ID00382904439255
Catalog number443925
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information