FDA-Device2020-06-17Class II
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Qiagen Sciences LLC
Hazard
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
Sold states
US Nationwide.
Affected count
530 kits within expiry
Manufactured in
19300 Germantown Rd, N/A, Germantown, MD, United States
Products
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2020Don't want to check this manually?
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