Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Device OraQuick® In-Home HIV Test
Classification Namehiv self-tests
Generic Namehiv self-tests
Applicant
OraSure Technologies, Inc
220 east first street
Bethlehem , PA 18015 -1360
  
PMA NumberBP120001
Supplement NumberS021
Date Received08/31/2012
Decision Date11/30/2012
Decision Approved
Product Code
QSS[ Registered Establishments with QSS ]
Advisory Committee Microbiology
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
-
-