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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack

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


Letter

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)

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448