Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
Medical specialty
Unknown
Device class
N
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens