Device typeMultiple-type meningitis 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 pathogens associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Pathogens detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus.
FDA categoryMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device ID00815381020130
Catalog numberRFIT-ASY-0119
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information