QUANTIFERON-TB

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Premarket Approval P010033 S001

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 in the manufacturing of microtiter plates from a semi-manual to an automated process.

DeviceQUANTIFERON-TB
Classification NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantQIAGEN
Date Received2002-10-07
Decision Date2002-10-24
PMAP010033
SupplementS001
Product CodeNCD
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN 19300 Germantown Road germantown, MD 20874

Supplemental Filings

Supplement NumberDateSupplement Type
P010033Original Filing
S048 2022-09-30 Real-time Process
S047 2021-03-26 Normal 180 Day Track
S046 2019-11-06 30-day Notice
S045 2019-04-15 Real-time Process
S044 2019-04-04 30-day Notice
S043 2019-02-15 30-day Notice
S042 2018-12-13 30-day Notice
S041 2018-09-25 Real-time Process
S040 2018-09-07 30-day Notice
S039 2018-02-28 30-day Notice
S038 2018-01-26 30-day Notice
S037 2018-01-11 135 Review Track For 30-day Notice
S036 2017-11-13 30-day Notice
S035 2017-10-31 30-day Notice
S034 2017-05-24 30-day Notice
S033 2017-04-12 30-day Notice
S032 2017-02-06 30-day Notice
S031 2016-12-09 Normal 180 Day Track
S030 2016-07-28 30-day Notice
S029 2016-07-21 30-day Notice
S028 2016-03-25 30-day Notice
S027
S026 2014-11-10 30-day Notice
S025 2014-10-24 Normal 180 Day Track No User Fee
S024 2014-04-23 30-day Notice
S023 2013-12-23 30-day Notice
S022
S021
S020 2012-04-11 Normal 180 Day Track
S019 2011-08-04 Special (immediate Track)
S018 2011-02-23 30-day Notice
S017 2010-08-30 Special (immediate Track)
S016 2010-05-20 135 Review Track For 30-day Notice
S015 2009-06-10 135 Review Track For 30-day Notice
S014 2009-06-02 135 Review Track For 30-day Notice
S013 2008-06-10 Real-time Process
S012 2007-03-16 Normal 180 Day Track No User Fee
S011 2006-06-01 Normal 180 Day Track
S010 2006-02-14 Special (immediate Track)
S009 2005-11-22 Normal 180 Day Track No User Fee
S008
S007 2004-01-14 30-day Notice
S006 2003-12-04 Normal 180 Day Track
S005 2003-04-18 30-day Notice
S004 2003-02-28 Real-time Process
S003 2003-02-20 Special (immediate Track)
S002 2002-12-02 30-day Notice
S001 2002-10-07 30-day Notice

NIH GUDID Devices

Device IDPMASupp
14053228033568 P010033 000
14053228033575 P010033 000
04053228002116 P010033 000
04053228002109 P010033 000
14053228002120 P010033 000
14053228002137 P010033 000
14053228002144 P010033 000
14053228002151 P010033 000
14053228015885 P010033 031
14053228015892 P010033 031
14053228015908 P010033 031
14053228015915 P010033 031
04053228015864 P010033 031
04053228015871 P010033 031

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