• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002