Simplifying Global Compliance
FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations
WHO Preapproves HIV Combo Test
Aug. 1, 2016
Alere’s HIV combo test has received World Health Organization prequalification status.
The fourth-generation test detects both HIV-1/2 antibodies and the HIV-1 p24 antigen.
The WHO prequalification status means it will be available for public sector procurement in poorer nations. — Tamra Sami
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