This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) |
| Classification Name | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex |
| Generic Name | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex |
| Applicant | GEN-PROBE, INC. |
| Date Received | 1994-07-11 |
| Decision Date | 1995-12-15 |
| Notice Date | 1997-06-18 |
| PMA | P940034 |
| Supplement | S |
| Product Code | MWA |
| Docket Number | 97M-0184 |
| Advisory Committee | Microbiology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | GEN-PROBE, INC. 10210 Genetic Center Dr. san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940034 | Original Filing | |
| S019 | 2012-11-07 | 30-day Notice |
| S018 | 2010-03-31 | 30-day Notice |
| S017 | 2006-07-27 | 135 Review Track For 30-day Notice |
| S016 | 2004-09-21 | 30-day Notice |
| S015 | 2004-01-22 | 30-day Notice |
| S014 | ||
| S013 | 2001-12-18 | Special (immediate Track) |
| S012 | 2001-03-02 | Normal 180 Day Track |
| S011 | 2000-10-25 | Real-time Process |
| S010 | 1999-05-12 | 30-day Notice |
| S009 | 1998-10-19 | Special (immediate Track) |
| S008 | 1998-09-04 | Panel Track |
| S007 | 1998-08-17 | Normal 180 Day Track |
| S006 | 1997-09-15 | Normal 180 Day Track |
| S005 | 1997-07-02 | Normal 180 Day Track |
| S004 | 1997-01-24 | Normal 180 Day Track |
| S003 | 1996-06-17 | Normal 180 Day Track |
| S002 | 1996-05-22 | Special (immediate Track) |
| S001 | 1996-02-23 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 15420045500303 | P940034 | 019 |