DIGENE HC2 SYSTEM SOFTWARE

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P890064 S031

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 the upgrade of the hc2 software suite to version 4. 3.

DeviceDIGENE HC2 SYSTEM SOFTWARE
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantQIAGEN GAITHERSBURG, INC
Date Received2014-09-23
Decision Date2014-10-09
PMAP890064
SupplementS031
Product CodeMAQ
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN GAITHERSBURG, INC 1900 Germantown Road germantown, MD 20874

Supplemental Filings

Supplement NumberDateSupplement Type
P890064Original Filing
S041 2020-05-20 30-day Notice
S040 2018-02-28 30-day Notice
S039 2018-02-16 30-day Notice
S038 2018-02-16 30-day Notice
S037 2018-01-26 30-day Notice
S036 2018-01-11 30-day Notice
S035 2017-11-30 30-day Notice
S034 2017-06-29 30-day Notice
S033 2016-02-19 Real-time Process
S032 2015-04-28 Normal 180 Day Track No User Fee
S031 2014-09-23 Real-time Process
S030 2014-03-21 Real-time Process
S029 2013-08-15 Normal 180 Day Track No User Fee
S028
S027 2011-07-28 Normal 180 Day Track No User Fee
S026 2011-02-28 Real-time Process
S025 2011-02-28 30-day Notice
S024 2010-04-15 30-day Notice
S023 2010-04-15 30-day Notice
S022 2010-04-15 30-day Notice
S021 2010-02-03 Normal 180 Day Track No User Fee
S020 2008-01-29 Normal 180 Day Track No User Fee
S019
S018 2006-03-24 Real-time Process
S017 2004-11-19 Special (immediate Track)
S016
S015 2004-05-28 Real-time Process
S014 2003-11-05 Normal 180 Day Track
S013 2003-10-01 Real-time Process
S012 2003-05-20 Special (immediate Track)
S011
S010
S009 2001-10-01 Panel Track
S008 2000-08-25 Normal 180 Day Track
S007 2000-02-07 Normal 180 Day Track
S006 1997-09-30 Normal 180 Day Track
S005 1996-11-01 Normal 180 Day Track
S004 1996-05-03 Normal 180 Day Track
S003 1993-09-27 Normal 180 Day Track
S002 1992-12-09 Normal 180 Day Track
S001 1991-10-18 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04053228010777 P890064 000
04053228002031 P890064 000
04053228002024 P890064 000
04053228002000 P890064 000
14053228002014 P890064 000
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