Tag Archives: Alere

June 2017—Alere announced that its Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a variety of lateral flow immunoassay formats and that can be used in point-of-care and laboratory settings, received FDA 510(k) clearance.

November 2016—Alere announced it has achieved in vitro diagnostic CE marking in Europe for its Alere Reader, a diagnostic analyzer that can be used in point-of-care and laboratory settings. The Alere Reader will be available initially for use with the Alere BinNow Legionella and Streptococcus pneumonia antigen cards, with other lateral flow applications and assays to follow.

Alere has received FDA approval to market its Alere Determine HIV-1/2 Ag/Ab Combo in the United States. The Alere Determine HIV-1/2 Ag/Ab Combo is a rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.