Biocompatibility Genotoxicity

Genotoxicity – Chromosomal Aberation / Mammalian Cells – Japanese MHLW (V0837)

Test Options/Variations

V0837-100Method 1
V0837-200Method 2

Genotoxicity studies are conducted to detect the risk of gene mutations, change in number or structure of a cell, and chromosomal or DNA damage caused by a medical device, bio-material, or their extracts. Since no single test can detect all genotoxic agents, a battery approach is usually taken to meet study and regulatory objective utilizing both mammalian and non-mammalian cell culture models

The purpose of this study is to determine if a test extract induces a pyrogenic response following intravenous injection in additional subjects after the initial test had a equivocal result


Japanese MHLW

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