Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.
| Device | Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2017-06-27 |
| Decision Date | 2017-09-01 |
| PMA | P080026 |
| Supplement | S021 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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