DiaSorin, Roche, Inova Diagnostics Receive FDA 510(k) Clearances in February

NEW YORK ─ The US Food and Drug Administration in February granted 510(k) clearances for tests from DiaSorin, Roche Diagnostics, and Inova Diagnostics, according to the agency's website.

DiaSorin nabbed a clearance for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus in serum and plasma samples. The laboratory-based test, performed on DiaSorin's Liaison analyzers, detects current or previous hepatitis A infections and the presence of an antibody response to the hepatitis A virus in vaccine recipients.