Parvovirus B19 IgG Enzyme Immunoassay

FDA Premarket Approval P970054 S020

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 IgG Enzyme Immunoassay
Generic NameAssay,enzyme Linked Immunosorbent,parvovirus B19 Igg
ApplicantDIASORIN
Date Received2021-11-23
Decision Date2021-12-21
PMAP970054
SupplementS020
Product CodeMYL 
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
P970054Original Filing
S020 2021-11-23 30-day Notice
S019 2020-07-16 30-day Notice
S018 2020-03-30 30-day Notice
S017
S016
S015 2018-08-08 Normal 180 Day Track No User Fee
S014
S013 2017-02-08 30-day Notice
S012 2016-12-22 30-day Notice
S011 2016-02-02 30-day Notice
S010 2013-11-27 30-day Notice
S009 2011-06-24 Normal 180 Day Track No User Fee
S008 2010-02-17 30-day Notice
S007 2009-02-09 30-day Notice
S006 2007-07-31 30-day Notice
S005 2007-06-04 135 Review Track For 30-day Notice
S004 2007-05-14 30-day Notice
S003
S002 2005-03-23 30-day Notice
S001 2002-11-15 Special (immediate Track)

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