510(k) for Gull Laboratories' EBV ELISA:
This article was originally published in Clinica
Gull Laboratories (US) has received US FDA 510(k) clearance to market its EBNA ELISA IgG test. The kit detects antibodies to the nuclear antigen of Epstein-Barr virus (EBV), thereby assisting in the diagnosis of EBV-associated diseases such as infectious mononucleosis. The first of Gull's EBV kits to use rDNA technology, the EBNA ELISA IgG test is expected to be used as part of a test panel.
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