Qiagen Gmbhqiagen Strasse 1hilden 40724 Pma Numberp110027 Supplement Numbers014 Date Received05 19 2022 Decision Date06 17 2022 Product Code Owd Advisory Committee Pathology Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Qiagen Gmbhqiagen Strasse 1hilden 40724 Pma Numberp110027 Supplement Numbers014 Date Received05 19 2022 Decision Date06 17 2022 Product Code Owd Advisory Committee Pathology Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P110027S014 QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	therascreen KRAS RGQ PCR Kit	2022-06-17