Premarket Approval (PMA)

Note: this medical device record is a supplement.

• Device: VERSANT® HIV-1 RNA 3.0 Assay (bDNA)
• Classification Name: test, hiv detection
• Generic Name: hiv detection test
• Regulation Number: 866.3956
• Applicant: Siemens Medical Solutions Diagnostics; p.o. box 2466; Berkeley , CA 94702 -0466
• PMA Number: BP000028
• Supplement Number: S033
• Date Received: 02/16/2011
• Decision Date: 03/10/2011

• Decision: Approved
• 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