Parvovirus B19 IgM Enzyme Immunoassay

FDA Premarket Approval P970055 S022

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

To subcontract manufacturing equipment cleaning processes

DeviceParvovirus B19 IgM Enzyme Immunoassay
Generic NameAssay,enzyme Linked Immunosorbent,parvovirus B19 Igm
Date Received2021-11-23
Decision Date2021-12-21
Product CodeMYM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DIASORIN 1951 Northwestern Avenue stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P970055Original Filing
S022 2021-11-23 30-day Notice
S021 2020-07-16 30-day Notice
S020 2020-03-30 30-day Notice
S019 2019-03-22 30-day Notice
S017 2018-08-08 Normal 180 Day Track No User Fee
S015 2017-02-08 30-day Notice
S014 2016-12-22 30-day Notice
S013 2013-11-27 30-day Notice
S012 2011-12-06 30-day Notice
S011 2011-07-06 30-day Notice
S010 2011-06-24 Normal 180 Day Track No User Fee
S009 2010-05-14 30-day Notice
S008 2010-02-17 30-day Notice
S007 2009-02-09 30-day Notice
S006 2007-07-31 30-day Notice
S005 2007-06-01 135 Review Track For 30-day Notice
S004 2007-05-14 30-day Notice
S002 2005-03-23 30-day Notice
S001 2002-11-15 Special (immediate Track)

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