Device |
antisera, fluorescent, human metapneumovirus |
Regulation Description |
Respiratory viral panel multiplex nucleic acid assay. |
Definition |
It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. |
Product Code | OMG |
Regulation Number |
866.3980
|
Device Class |
2
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