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.
Approval for labeling changes to strengthen contraindications to the rapid gram negative procedural manuals for both mic and breakpoint formats, which describes a limitation for performance characteristics for esbl producing organisms and a limitation for those organisms (e. G. , enterobacter species) which express inducible beta-lactamase enzymes.
| Device | MICROSCAN RAPID FLUOROGENIC PANELS |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | DADE INTL., INC. |
| Date Received | 2001-10-12 |
| Decision Date | 2001-11-09 |
| PMA | P870049 |
| Supplement | S031 |
| Product Code | LON |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DADE INTL., INC. 1584 Enterprise Blvd. west Sacramento,, CA 95691 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870049 | Original Filing | |
| S032 | 2001-11-05 | Normal 180 Day Track |
| S031 | 2001-10-12 | Special (immediate Track) |
| S030 | 2000-05-17 | Special (immediate Track) |
| S029 | 1999-06-10 | Special (immediate Track) |
| S028 | 1999-01-04 | Special (immediate Track) |
| S027 | 1998-06-09 | Special (immediate Track) |
| S026 | ||
| S025 | 1995-09-28 | Normal 180 Day Track |
| S024 | 1995-08-01 | Normal 180 Day Track |
| S023 | 1995-02-22 | Normal 180 Day Track |
| S022 | 1994-09-30 | Special (immediate Track) |
| S021 | 1994-09-13 | Special (immediate Track) |
| S020 | 1993-10-20 | Special (immediate Track) |
| S019 | ||
| S018 | 1993-04-21 | Normal 180 Day Track |
| S017 | ||
| S016 | 1992-01-08 | Normal 180 Day Track |
| S015 | 1991-11-29 | Normal 180 Day Track |
| S014 | 1991-08-22 | Normal 180 Day Track |
| S013 | 1991-06-28 | Normal 180 Day Track |
| S012 | 1991-05-21 | Normal 180 Day Track |
| S011 | 1991-05-17 | Normal 180 Day Track |
| S010 | 1990-11-21 | Normal 180 Day Track |
| S009 | 1990-11-07 | Normal 180 Day Track |
| S008 | 1990-10-25 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 1989-12-26 | Normal 180 Day Track |
| S004 | 1989-07-20 | Normal 180 Day Track |
| S003 | 1989-03-20 | Normal 180 Day Track |
| S002 | 1989-03-02 | Normal 180 Day Track |
| S001 | 1988-12-13 | Normal 180 Day Track |