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MBio Achieves ISO 13485:2003 Certification

NEW YORK (GenomeWeb News) – MBio Diagnostics today said that it has achieved ISO 13485:2003 certification for its quality management system.

The certification means that the Boulder, Colo.-based company has demonstrated that it fulfills certain quality system requirements to provide medical devices and related services that consistently meet customer demands. ISO 13485:2003 certification is often the initial step toward obtaining the CE mark in Europe and in countries that honor the mark.

"Achieving this certification is a significant milestone for MBio Diagnostics that brings us closer to the launch of our first product, the MBio CD4 System," MBio CEO Christopher Myatt said in a statement.

The CD4 System is a point-of-care CD4 testing device. CD4 T helper cell destruction is the central immunological feature of HIV infection, MBio said on its website, and CD4 count is crucial in monitoring the progression of HIV. MBio is also developing its MBio Array System, a multiplex fluorescence immunoassay platform for measuring multiple analytes in a single sample.

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