Premarket Approval (PMA)

Note: this medical device record is a supplement.

• Device: Vironostika HIV-1 Plus O Microelisa System
• Classification Name: test, hiv detection
• Generic Name: hiv detection test
• Regulation Number: 866.3956
• Applicant: BioMerieux, Inc.; 100 rodolphe street; Durham , NC 27712
• PMA Number: BP020066
• Supplement Number: S003
• Date Received: 01/14/2004
• Decision Date: 02/12/2004

• 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