Approval for 1) the addition of an optional extended use feature to allow prepared amplification master mix and internal control to be used second time within 14 days of initial use if stored at 2°c to 8°c; 2) improvements to the preparation and processing steps of the amplification master mix by the abbott m2000sp instrument; and 3) associated software revisions.
| Device | HBV ASSAY |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2013-02-15 |
| Decision Date | 2013-10-15 |
| PMA | P080026 |
| Supplement | S006 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080026 | | Original Filing |
| S024 |
2021-02-05 |
30-day Notice |
| S023 |
2020-11-16 |
30-day Notice |
| S022 |
2019-04-10 |
30-day Notice |
| S021 |
2017-06-27 |
135 Review Track For 30-day Notice |
| S020 |
2016-12-01 |
30-day Notice |
| S019 |
2016-11-16 |
30-day Notice |
| S018 |
2016-10-27 |
30-day Notice |
| S017 |
2016-03-28 |
30-day Notice |
| S016 |
2015-07-29 |
Real-time Process |
| S015 | | |
| S014 |
2015-03-26 |
30-day Notice |
| S013 |
2014-11-10 |
30-day Notice |
| S012 |
2014-10-24 |
30-day Notice |
| S011 |
2013-11-12 |
30-day Notice |
| S010 |
2013-10-21 |
30-day Notice |
| S009 |
2013-07-23 |
30-day Notice |
| S008 |
2013-07-11 |
Real-time Process |
| S007 |
2013-05-01 |
30-day Notice |
| S006 |
2013-02-15 |
Normal 180 Day Track |
| S005 |
2012-12-26 |
30-day Notice |
| S004 |
2012-10-04 |
30-day Notice |
| S003 |
2012-04-02 |
135 Review Track For 30-day Notice |
| S002 |
2011-07-01 |
135 Review Track For 30-day Notice |
| S001 | | |
NIH GUDID Devices