Approval to extend the expiration dating of reagents, calibrators, and controls to 14 months. The device, as modified, will be marketed under the trade name architect anti-hcv and is indicated for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult and pediatric serum and plasma (potassium edta, lithium heparin, and sodium heparin).
| Device | ARCHITECT ANTI-HCV |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2007-01-11 |
| Decision Date | 2007-03-05 |
| PMA | P050042 |
| Supplement | S002 |
| Product Code | MZO |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept 09vb abbott Park, IL 60064 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050042 | | Original Filing |
| S047 |
2021-11-18 |
30-day Notice |
| S046 |
2021-11-09 |
30-day Notice |
| S045 |
2021-02-09 |
Real-time Process |
| S044 |
2020-07-31 |
30-day Notice |
| S043 |
2020-04-08 |
30-day Notice |
| S042 | | |
| S041 | | |
| S040 | | |
| S039 |
2019-07-18 |
30-day Notice |
| S038 |
2018-12-28 |
30-day Notice |
| S037 |
2018-10-12 |
30-day Notice |
| S036 |
2018-10-10 |
30-day Notice |
| S035 |
2018-09-21 |
30-day Notice |
| S034 | | |
| S033 |
2016-02-29 |
30-day Notice |
| S032 |
2015-07-16 |
30-day Notice |
| S031 |
2014-11-13 |
30-day Notice |
| S030 |
2014-09-19 |
30-day Notice |
| S029 |
2014-04-01 |
30-day Notice |
| S028 |
2013-10-30 |
30-day Notice |
| S027 |
2013-10-28 |
30-day Notice |
| S026 |
2013-10-18 |
30-day Notice |
| S025 |
2013-08-05 |
30-day Notice |
| S024 |
2013-04-23 |
30-day Notice |
| S023 |
2013-02-15 |
30-day Notice |
| S022 |
2013-02-11 |
30-day Notice |
| S021 |
2012-11-19 |
30-day Notice |
| S020 |
2012-11-15 |
30-day Notice |
| S019 |
2012-11-13 |
30-day Notice |
| S018 |
2012-08-03 |
30-day Notice |
| S017 |
2012-07-05 |
30-day Notice |
| S016 |
2012-03-15 |
30-day Notice |
| S015 |
2011-11-23 |
Special (immediate Track) |
| S014 |
2011-10-28 |
30-day Notice |
| S013 |
2011-05-25 |
30-day Notice |
| S012 |
2011-05-04 |
Normal 180 Day Track No User Fee |
| S011 |
2011-04-18 |
30-day Notice |
| S010 |
2011-02-17 |
Normal 180 Day Track No User Fee |
| S009 |
2011-01-19 |
30-day Notice |
| S008 |
2010-12-22 |
Special (immediate Track) |
| S007 |
2010-11-01 |
Normal 180 Day Track No User Fee |
| S006 |
2010-08-02 |
Normal 180 Day Track No User Fee |
| S005 |
2009-01-28 |
Normal 180 Day Track |
| S004 |
2008-12-23 |
30-day Notice |
| S003 |
2007-10-29 |
Real-time Process |
| S002 |
2007-01-11 |
Real-time Process |
| S001 |
2006-06-08 |
135 Review Track For 30-day Notice |
NIH GUDID Devices