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: GS HIV Combo Ag/Ab EIA
• Classification Name: test, hiv detection
• Generic Name: hiv detection test
• Regulation Number: 866.3956
• Applicant: Bio-Rad Laboratories, Inc.; 6565 185th avenue ne; Redmond , WA 98052
• PMA Number: BP100064
• Supplement Number: S008
• Date Received: 09/24/2012
• Decision Date: 10/17/2012

• Decision: 30-Day Notice - No 135-Day Supplement Needed
• Product Code: MZF [ Registered Establishments with MZF ]
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No