Premarket Approval (PMA)

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: OraSure HIV-1 Western Blot Kit
• Classification Name: point of care hiv serology diagnostic and/or supplemental test
• Generic Name: point of care hiv serology diagnostic and/or supplemental test
• Regulation Number: 866.3956
• Applicant: OraSure Technologies, Inc; 220 east first street; Bethlehem , PA 18015 -1360
• PMA Number: BP950004
• Supplement Number: S005
• Date Received: 10/08/2004
• Decision Date: 01/27/2005

• Decision: Approved
• Product Code: QSU [ Registered Establishments with QSU ]
• Advisory Committee: Microbiology
• Supplement Type: 135 Day Track for 30 Day Notification
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No