BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg

FDA Premarket Approval P970054 S008

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

Introduction of a new production procedure to prepare a viral master stock, and the documentation of the tubing priming steps for the plate coating equipment used in the device.

DeviceBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE
Classification NameAssay,enzyme Linked Immunosorbent,parvovirus B19 Igg
Generic NameAssay,enzyme Linked Immunosorbent,parvovirus B19 Igg
ApplicantDIASORIN
Date Received2010-02-17
Decision Date2010-03-19
PMAP970054
SupplementS008
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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