Diagnostic Products Corporation announced the approval by Lloyd's Register Quality Assurance Ltd (LRQA) to CE Mark a total of nineteen diagnostic tests for infectious disease measurement in plasma or serum.
These approvals, among the first in the European Union (EU) by LRQA, include tests for Hepatitis B, Toxoplasma, Rubella and Cytomegalovirus (CMV) on the IMMULITE 2000 and IMMULITE Automated Immunoassay Analyzer Systems.
DPC President, Michael Ziering said that, "These products are the first of the company's expanding menu of Infectious Disease assays to be approved for the CE Mark and demonstrate that DPC is strongly committed to the infectious disease diagnostic market and customer demand. Applications have been made to the FDA for approval of Hepatitis Markers on both the IMMULITE 2000 and IMMULITE systems in the US."
LRQA is working together with the Paul Ehrlich Institute (PEI-IVD) of Langen, Germany, a respected accredited laboratory providing subcontracted testing services for the EU IVD Directive.
Consequently, all DPC Hepatitis B markers receive verification testing at the PEI-IVD laboratory prior to placement on the market. The full list of the CE Marked products approved by LRQA/PEI on both systems is HBsAg and HBsAg Confirmatory, anti-HBs, anti-HBc, anti-HBc IgM, Toxoplasma IgG and IgM, Rubella IgG and IgM and CMV IgG.