FDA-Device2019-10-30Class II
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Luminex Molecular Diagnostics
Hazard
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
Sold states
US distribution to CA, CT, MA, and PA OUS: None
Affected count
56 Kits
Manufactured in
439 University Ave Suite 900, Toronto, Canada
Products
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0161-2020Don't want to check this manually?
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