Month: September 2008

Focus Diagnostics Receives FDA 510(k) Clearance for Test Kits Detecting Epstein-Barr Virus Antibodies

Focus Diagnostics, Inc has received 510(k) clearance from the U.S. Food and Drug Administration to market its two new Plexus EBV Multi-Analyte Diagnostics serology test kits for detecting the presence or absence of IgG and IgM antibodies in blood serum. The two tests are indicated as aids in the diagnosis of Epstein-Barr virus infection and EBV-associated infectious mononucleosis.

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