Device typeMultiple-type biothreat/febrile infection-associated 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 (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen, using a nucleic acid technique (NAT). It is typically used to aid diagnosis incidences of suspected exposure to biological agents used in bioterrorism or biological warfare.
FDA categoryDirect Blood Bacterial Nucleic Acid Detection System, Instrumentation For Clinical Multiplex Test Systems, Multiplex Nucleic Acid Detection System For Biothreat Agents
Device IDM70880113943
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information