Abbott RealTime HCV Genotype II Assay

Assay, Genotyping, Hepatitis C Virus

FDA Premarket Approval P120012 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

Modify the manufacturing and qc testing for a kit component and tighten an incoming reagent specification.

DeviceAbbott RealTime HCV Genotype II Assay
Classification NameAssay, Genotyping, Hepatitis C Virus
Generic NameAssay, Genotyping, Hepatitis C Virus
Date Received2018-05-25
Decision Date2018-06-21
Product CodeOBF
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P120012Original Filing
S019 2021-02-05 30-day Notice
S018 2019-04-10 30-day Notice
S017 2018-05-25 30-day Notice
S016 2017-06-27 135 Review Track For 30-day Notice
S015 2016-12-01 30-day Notice
S014 2016-06-01 30-day Notice
S013 2016-04-20 30-day Notice
S012 2016-03-28 30-day Notice
S011 2016-03-25 30-day Notice
S010 2015-12-16 Real-time Process
S009 2015-07-29 Real-time Process
S007 2015-03-26 30-day Notice
S006 2014-11-10 30-day Notice
S005 2014-10-24 30-day Notice
S004 2014-08-28 30-day Notice
S003 2013-07-23 30-day Notice
S002 2013-07-15 30-day Notice
S001 2013-07-12 30-day Notice


Device IDPMASupp
00884999036444 P120012 001
00884999036147 P120012 001
00884999036130 P120012 001
00884999034266 P120012 001
00884999042513 P120012 010

© 2024
This site is not affiliated with or endorsed by the FDA.