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: INSTI TM HIV-1/HIV-2 Antibody Test.
• 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: bioLytical Laboratories, Inc; 1108-13351 commerce parkway; Richmond ; british columbia CA V6V 2X7
• PMA Number: BP090032
• Supplement Number: S007
• Date Received: 05/22/2014
• Decision Date: 01/28/2015

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