digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P890064 S033

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 a new version of the hc2 software suite (version 4. 4) and a new hardware model of the pc used with this software.

Devicedigene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantQIAGEN GAITHERSBURG, INC
Date Received2016-02-19
Decision Date2016-04-15
PMAP890064
SupplementS033
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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