FDA-Device2021-02-03Class II
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Qiagen Sciences LLC
Hazard
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Sold states
CA, IN, MI, MN, NC, NJ, NM, OH, TX
Affected count
575 kits US
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2021Don't want to check this manually?
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