Lophius Biosciences Completes Two Important Regulatory Milestones
Lophius Biosciences has announced the successful realization of two important regulatory milestones.
Lophius Biosciences, a leader in the field of novel T-cell based diagnostic test systems, has announced the successful realization of two important regulatory milestones.
With the successful completion of the EN ISO 13485 certification, the company established all prerequisites for a quality management system to meet customer and regulatory requirements applicable to medical devices according to the European IVD guidelines.
In addition, the company announced that it has received CE-marking for its T-Track? CMV and T-Track? EBV tests following successful clinical validation of both products by measuring functional effector cells of the cell-mediated immune system (CMI) in a cohort of > 120 hemodialysis patients.
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