ABBOTT REALTIME HCV ASSAY

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

FDA Premarket Approval P100017 S009

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

Manufacturing change conversion from a manual to an automated kit packaging system.

DeviceABBOTT REALTIME HCV ASSAY
Classification NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantABBOTT MOLECULAR, INC.
Date Received2013-11-12
Decision Date2013-12-11
PMAP100017
SupplementS009
Product CodeMZP
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P100017Original Filing
S024 2021-02-05 30-day Notice
S023 2020-11-16 30-day Notice
S022 2019-04-10 30-day Notice
S021 2018-05-25 30-day Notice
S020 2017-06-27 135 Review Track For 30-day Notice
S019 2016-12-01 30-day Notice
S018 2016-06-01 30-day Notice
S017 2016-04-20 30-day Notice
S016 2016-03-28 30-day Notice
S015 2016-03-25 30-day Notice
S014 2015-07-29 Real-time Process
S013
S012 2015-03-26 30-day Notice
S011 2014-11-10 30-day Notice
S010 2014-10-24 30-day Notice
S009 2013-11-12 30-day Notice
S008 2013-10-21 30-day Notice
S007 2013-07-23 30-day Notice
S006 2013-05-01 30-day Notice
S005 2013-03-01 Normal 180 Day Track
S004 2013-02-04 30-day Notice
S003 2012-10-04 30-day Notice
S002 2012-04-02 135 Review Track For 30-day Notice
S001 2011-07-01 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999042681 P100017 014

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