Skin sensitization assay for safety assessment of medical devices and solid materials
CompanySenzaGen, Lund, Sweden
The GARD®skin Medical Device from SenzaGen is a quantitative, standardized test method for evaluating medical devices and solid compounds. The method is based on GARDskin technology, which uses AI-based gene expression analysis to differentiate between valid sensitizing and non-sensitizing substances and can thereby predict potential allergic skin reactions. The assay meets the requirements of the ISO Guideline for the Evaluation of Biological Medical Devices (ISO 10993) and supports polar (saline) and non-polar (oil) extraction vehicles as recommended. The machine learning platform generates meaningful results within 4–8 weeks that can help accelerate safety testing and approval of new biomedical products.
GARD®skin Medical Device. In vitro skin sensitization testing for medical devices and solid materials
info@senzagen.com
Added on: 11-21-2023
[1] https://senzagen.com/in-vitro-biocompatibility-testing/skin-sensitization-with-gard-iso-10993-10/
