Approval for: 1)a component (nalc) in a liquid reagent (enzyme dilution buffer) is moved to a lyophilized reagent (enzyme reagent), resulting in a stability shelf life of 1 year for the reagents and 1 year for the kit; 2) add an additional vendor of reverse transcriptase; and, 3) insignificant changes to the package insert
| 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 | 1996-02-23 |
| Decision Date | 1996-04-23 |
| PMA | P940034 |
| Supplement | S001 |
| Product Code | MWA |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE, INC. 10210 Genetic Center Dr. san Diego, CA 92121 |
Supplemental Filings
| 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 |
NIH GUDID Devices