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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant QIAGEN GmbH productcode OWD Decision Date To 05/17/2024
 
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PMA
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therascreen PIK3CA RGQ PCR Kit QIAGEN GMBH P190001 S001 04/03/2020
therascreen PIK3CA RGQ PCR Kit QIAGEN GmbH P190004 05/24/2019
therascreen PIK3CA RGQ PCR Kit QIAGEN GMBH P190001 05/24/2019
therascreen PDGFRA RGQ PCR Kit QIAGEN GmbH P210002 06/29/2023
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 S009 11/09/2015
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 S008 08/06/2015
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 S005 02/19/2015
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 S002 01/15/2015
therascreen KRAS RGQ PCR Kit QIAGEN GmbH P110027 S010 04/06/2018
therascreen KRAS RGQ PCR Kit QIAGEN GmbH P110027 S014 06/17/2022
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