OraQuick HCV Rapid Antibody Test

FDA Premarket Approval P080027 S039

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Manufacturing process improvements

DeviceOraQuick HCV Rapid Antibody Test
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantORASURE TECHNOLOGIES INC.
Date Received2021-03-25
Decision Date2021-04-20
PMAP080027
SupplementS039
Product CodeMZO 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ORASURE TECHNOLOGIES INC. 220 East First Street bethlehem, PA 18015

Supplemental Filings

Supplement NumberDateSupplement Type
P080027Original 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

Device IDPMASupp
00608337000542 P080027 001
20608337000539 P080027 001

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.