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Ortho-Clinical Diagnostics Vitros ECi

This article was originally published in The Gray Sheet

Executive Summary

Test menu for fully-automated, random-access immunodiagnostic system includes anti-hepatitis B core (anti-HBc) and anti-HBc IgM assays to aid in diagnosing hepatitis B, following recent PMA approval. The two additions to the system complement three previously approved hepatitis assays - anti-HBs, HBsAg and anti-HCV. The Johnson & Johnson subsidiary debuted its Vitros anti-HAV total assay on the ECi system outside the U.S. in December. Anti-HIV 1+2 assay U.S. trials are "nearly complete," and the firm plans 510(k) submissions later this year for IgM and IgG assays for toxoplasma, rubella and CMV...



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