Manufacture additional lateral flow platform devices in a common production area and to share manufacturing equipment.
| Device | OraQuick HCV Rapid Antibody Test |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ORASURE TECHNOLOGIES INC. |
| Date Received | 2018-01-08 |
| Decision Date | 2018-02-01 |
| PMA | P080027 |
| Supplement | S032 |
| Product Code | MZO |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORASURE TECHNOLOGIES INC. 220 East First Street bethlehem, PA 18015 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080027 | | Original Filing |
| S039 |
2021-03-25 |
30-day Notice |
| S038 |
2021-02-01 |
30-day Notice |
| S037 |
2020-09-14 |
30-day Notice |
| S036 | | |
| S035 |
2019-08-16 |
30-day Notice |
| S034 |
2018-11-07 |
30-day Notice |
| S033 |
2018-03-13 |
30-day Notice |
| S032 |
2018-01-08 |
30-day Notice |
| S031 |
2017-12-08 |
30-day Notice |
| S030 |
2017-09-14 |
30-day Notice |
| S029 |
2017-08-14 |
30-day Notice |
| S028 |
2017-06-07 |
30-day Notice |
| S027 |
2017-04-14 |
30-day Notice |
| S026 |
2017-01-30 |
30-day Notice |
| S025 |
2016-11-28 |
30-day Notice |
| S024 |
2016-10-24 |
30-day Notice |
| S023 |
2016-04-15 |
30-day Notice |
| S022 |
2016-02-01 |
30-day Notice |
| S021 |
2015-09-03 |
30-day Notice |
| S020 | | |
| S019 |
2014-12-23 |
30-day Notice |
| S018 |
2014-09-03 |
Special (immediate Track) |
| S017 |
2014-06-06 |
Real-time Process |
| S016 |
2014-03-04 |
Normal 180 Day Track |
| S015 |
2013-11-19 |
30-day Notice |
| S014 |
2013-09-06 |
30-day Notice |
| S013 |
2013-08-28 |
30-day Notice |
| S012 |
2013-07-12 |
Special (immediate Track) |
| S011 |
2013-04-29 |
Special (immediate Track) |
| S010 |
2013-02-21 |
30-day Notice |
| S009 |
2013-02-19 |
Special (immediate Track) |
| S008 |
2012-12-28 |
30-day Notice |
| S007 |
2012-11-28 |
Special (immediate Track) |
| S006 |
2011-04-06 |
30-day Notice |
| S005 |
2011-03-16 |
135 Review Track For 30-day Notice |
| S004 | | |
| S003 |
2011-02-23 |
135 Review Track For 30-day Notice |
| S002 | | |
| S001 |
2010-08-03 |
Panel Track |
NIH GUDID Devices