Qiagen19300 Germantown Roadgermantown Md 20874 Pma Numberp010033 Supplement Numbers048 Date Received09 30 2022 Decision Date01 24 2023 Product Code Ncd Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Qiagen19300 Germantown Roadgermantown Md 20874 Pma Numberp010033 Supplement Numbers048 Date Received09 30 2022 Decision Date01 24 2023 Product Code Ncd Advisory Committee Microbiology Supplement Typereal Time Process 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 P010033S048 QIAGEN19300 Germantown Roadgermantown, MD 20874 PMA NumberP010033 Supplement NumberS048 Date Received09/30/2022 Decision Date01/24/2023 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	QUANTIFERON®-TB Gold Plus Test	2023-01-24