Diasorin Inc 1951 Northwestern Avenuestillwater Mn 55082 Pma Numberp180049 Supplement Numbers011 Date Received11 10 2022 Decision Date12 08 2022 Advisory Committee Microbiology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Diasorin Inc 1951 Northwestern Avenuestillwater Mn 55082 Pma Numberp180049 Supplement Numbers011 Date Received11 10 2022 Decision Date12 08 2022 Advisory Committee Microbiology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier 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 P180049S011 DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe	2022-12-08