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  1. Approved Blood Products

VITROS Immunodiagnostic Products HIV Combo Reagent Pack & VITROS Immunodiagnostic Products HIV Combo Calibrator

PMA: BP160122
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Tradename: VITROS Immunodiagnostic Products HIV Combo Reagent Pack/VITROS Immunodiagnostic Products HIV Combo Calibrator
Indication:

  • VITROS Immunodiagnostic Products HIV Combo Reagent Pack is for the simultaneous qualitative detection of antibodies to Human Immunodeficiency Virus types 1, including group M and O, and/or 2 (anti-HIV-1 and anti-HIV-2) and HIV p24 antigen in human serum and plasma (heparin and EDTA) in adults, pregnant women, adolescents and children (as young as 2 years of age), using the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System, and VITROS 5600 Integrated System.

  • VITROS Immunodiagnostic Products HIV Combo Calibrator is for use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System, and VITROS 5600 Integrated System with the VITROS HIV Combo Reagent Pack.

 Approval Date: December 13, 2017

Product Information

Supporting Documents

 
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