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Genotoxicity – Bacterial Reverse Mutation Study – Japanese MHLW

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 solution induces a pyrogenic response following intravenous injection in additional naive subjects after the original test had a equivocal result

Test Options/Variations

V0836-100 Method 1
V0836-200 Method 2