Approval for the addition of an optional extended use feature to allow prepared amplification master mix and internal control to be used a second time within 14 days of initial use if stored at -25°c to -15°c; 2) process improvements to the liquid level sensing performed by the abbott m2000sp instrument; 3) the conversion of manual plate filling to automated plate filling; and 4) associated software revisions.
| Device | ABBOTT REAL TIME HCV |
| Classification Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Generic Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2013-03-01 |
| Decision Date | 2013-09-25 |
| PMA | P100017 |
| Supplement | S005 |
| Product Code | MZP |
| 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 |
|---|
| P100017 | | Original Filing |
| S024 |
2021-02-05 |
30-day Notice |
| S023 |
2020-11-16 |
30-day Notice |
| S022 |
2019-04-10 |
30-day Notice |
| S021 |
2018-05-25 |
30-day Notice |
| S020 |
2017-06-27 |
135 Review Track For 30-day Notice |
| S019 |
2016-12-01 |
30-day Notice |
| S018 |
2016-06-01 |
30-day Notice |
| S017 |
2016-04-20 |
30-day Notice |
| S016 |
2016-03-28 |
30-day Notice |
| S015 |
2016-03-25 |
30-day Notice |
| S014 |
2015-07-29 |
Real-time Process |
| S013 | | |
| S012 |
2015-03-26 |
30-day Notice |
| S011 |
2014-11-10 |
30-day Notice |
| S010 |
2014-10-24 |
30-day Notice |
| S009 |
2013-11-12 |
30-day Notice |
| S008 |
2013-10-21 |
30-day Notice |
| S007 |
2013-07-23 |
30-day Notice |
| S006 |
2013-05-01 |
30-day Notice |
| S005 |
2013-03-01 |
Normal 180 Day Track |
| S004 |
2013-02-04 |
30-day Notice |
| S003 |
2012-10-04 |
30-day Notice |
| S002 |
2012-04-02 |
135 Review Track For 30-day Notice |
| S001 |
2011-07-01 |
135 Review Track For 30-day Notice |
NIH GUDID Devices