ABBOTT REALTIME HBV ASSAY

Hepatitis Viral B Dna Detection

FDA Premarket Approval P080026 S017

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

Change to consolidate the current qc testing for the amplification reagent kit from two stages into a single finished kit qc stage.

DeviceABBOTT REALTIME HBV ASSAY
Classification NameHepatitis Viral B Dna Detection
Generic NameHepatitis Viral B Dna Detection
ApplicantABBOTT MOLECULAR, INC.
Date Received2016-03-28
Decision Date2016-04-12
PMAP080026
SupplementS017
Product CodeMKT
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
P080026Original Filing
S024 2021-02-05 30-day Notice
S023 2020-11-16 30-day Notice
S022 2019-04-10 30-day Notice
S021 2017-06-27 135 Review Track For 30-day Notice
S020 2016-12-01 30-day Notice
S019 2016-11-16 30-day Notice
S018 2016-10-27 30-day Notice
S017 2016-03-28 30-day Notice
S016 2015-07-29 Real-time Process
S015
S014 2015-03-26 30-day Notice
S013 2014-11-10 30-day Notice
S012 2014-10-24 30-day Notice
S011 2013-11-12 30-day Notice
S010 2013-10-21 30-day Notice
S009 2013-07-23 30-day Notice
S008 2013-07-11 Real-time Process
S007 2013-05-01 30-day Notice
S006 2013-02-15 Normal 180 Day Track
S005 2012-12-26 30-day Notice
S004 2012-10-04 30-day Notice
S003 2012-04-02 135 Review Track For 30-day Notice
S002 2011-07-01 135 Review Track For 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
00884999046603 P080026 000
00884999042667 P080026 016

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