BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm

FDA Premarket Approval P970055 S010

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

Approval for a manufacturing site located at biotrin international ltd in dublin, ireland.

DeviceBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Classification NameAssay,enzyme Linked Immunosorbent,parvovirus B19 Igm
Generic NameAssay,enzyme Linked Immunosorbent,parvovirus B19 Igm
ApplicantDIASORIN
Date Received2011-06-24
Decision Date2012-09-05
PMAP970055
SupplementS010
Product CodeMYM
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation 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
S018
S017 2018-08-08 Normal 180 Day Track No User Fee
S016
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
S003
S002 2005-03-23 30-day Notice
S001 2002-11-15 Special (immediate Track)

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