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.
| Device | QUANTIFERON®-TB Gold Plus Test |
| Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Applicant | QIAGEN19300 Germantown Roadgermantown, MD 20874 PMA NumberP010033 Supplement NumberS048 Date Received09/30/2022 Decision Date01/24/2023 Product Code NCD Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2023-01-24 |
| PMA | P010033 |
| Supplement | S048 |
| Product Code | NCD |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN 19300 Germantown Road germantown, MD 20874 PMA NumberP010033 Supplement NumberS048 Date Received09/30/2022 Decision Date01/24/2023 Product Code NCD Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Addition Of Sodium Heparin Tubes As An Alternative For Blood Collection In The Workflow Of The Quantiferon TB Gold Plus Test |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010033 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 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 |