Diasorin

FDA Filings

This page includes the latest FDA filings for Diasorin. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P970055S022 DIASORIN	Parvovirus B19 IgM Enzyme Immunoassay	2021-12-21
PMA P970054S020 DIASORIN	Parvovirus B19 IgG Enzyme Immunoassay	2021-12-21
PMA P970055S021 DIASORIN	Parvovirus B19 IgM Enzyme Immunoassay	2020-08-13
PMA P970054S019 DIASORIN	Parvovirus B19 IgG Enzyme Immunoassay	2020-08-13
PMA P970055S020 DIASORIN	Parvovirus B19 IgM Enzyme Immunoassay	2020-04-21
PMA P970054S018 DIASORIN	Parvovirus B19 IgG Enzyme Immunoassay	2020-04-21
PMN K130321 DIASORIN	LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS	2013-04-09

Similar & Related FDA Registered Companies

• DiaSorin Inc.
• DiaSorin Molecular LLC
• DiaSorin S.p.A
• DIASORIN/AMERICAN STANDARD COMPANIES
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS008 Date Received09/21/2022 Decision Date12/21/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• 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
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS010 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS022 Date Received11/10/2022 Decision Date12/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS013 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
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS014 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS018 Date Received07/15/2022 Decision Date08/11/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS017 Date Received04/13/2022 Decision Date07/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS006 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS016 Date Received04/05/2022 Decision Date06/23/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS012 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS011 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS010 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS011 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS015 Date Received04/05/2022 Decision Date05/06/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS005 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS009 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS014 Date Received02/04/2022 Decision Date05/05/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS004 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS010 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DIASORIN IRELAND LIMITED

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091057105	Genova,Italy -> Norfolk, Virginia	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2020208009 DATED 17.08.20 TERMS EXW	21 PKG
2020081833567	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2022207095 DATED 14.07.20 TERMS EXW	21 PKG
2020081833581	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2020207150 DATED 16.07.20 TERMS EXW	21 PKG
2020081156724	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2022207095 DATED 14.07.20 TERMS EXW	21 PKG
2020081156749	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2020207150 DATED 16.07.20 TERMS EXW	21 PKG
2020072821156	Genova,Italy -> New York, New York	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2020206332 - 2020206333 DATED 18.06.2020 TERMS EXW	23 PKG
2020072817157	Genova,Italy -> New York, New York	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICES NO. 2020206090 DATED 11.06.20 2020206097 DATED 11.06.20 2020206098 DATED 11.06.20 TERMS EXW	23 PKG
2020072822403	Genova,Italy -> New York/Newark Area, Newark, New Jersey	LIAISON STARTER KIT HS CODE: 38220000 AS PER INVOICE NO 2020206230 DATED 16.06.20 TERMS EXW	21 PKG