FDA-Device2022-04-27Class II
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Qiagen Sciences LLC
Hazard
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Sold states
AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
Affected count
8 Kits
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2022Don't want to check this manually?
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