DPC is pleased to announce its official approval by Lloyd’s Register Quality Assurance (LRQA) to display the CE Mark on nineteen of DPC’s infectious disease immunoassay products. The IMMULITE^® and IMMULITE^® 2000 assays for hepatitis B, Toxoplasma, rubella and cytomegalovirus are the first such assays to receive this approval by LRQA, or indeed by any notified body.

DPC’s hepatitis B assays received technical approval from the Paul Ehrlich Institute (PEI) located in Langen, Germany, an expert laboratory recognized worldwide with which LRQA has established an alliance for infectious disease testing. Approval through the PEI was based on actual testing evaluation, prior to approval for market release.

The European Union (EU) requires that many products intended for sale within its member nations, including medical devices, bear the CE Mark. Accordingly, the CE Mark will appear on kits designated for EU countries.