Chembio Diagnostics’ Sure Check HIV 1/2 assay has received CE Mark approval. The assay is now cleared for commercialization within the EU for rapid point-of-care detection of HIV. The product is FDA approved and distributed in the United States as Clearview Complete HIV 1/2 by Alere.
Chembio is working with commercialization partners in Europe and expects sales of the Sure Check HIV 1/2 assay in the EU by the first quarter of 2014.
Chembio Diagnostics, 631-924-1135