Premarket Approval Information - Devices
Applicant: Ortho-Clinical Diagnostics, Inc
Product: VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator
VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack
PMA number: BP050051/0
Indication for Use: For the in vitro detection of antibodies to Human Immunodeficiency virus types 1 and/or 2 in human serum and plasma.
Approval Date: 3/27/2008
Summary of Safety and Effectiveness
Package Insert - VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator (PDF - 131 KB)
Package Insert - VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack (PDF - 621 KB)
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