Sensitization
Delayed hypersensitivity is the ISO 10993-10 question: whether a patient-contacting material teaches the immune system to react. This list is the Magnusson-Kligman guinea pig method and the in vitro KDPRA and KeratinoSens assays; sample amounts and turnaround live on each method page.
Sensitization is rarely ordered aloneFor a surface-contact device the ISO 10993-1:2025 baseline normally pairs sensitization with cytotoxicity and irritation. If you do not yet have a biological evaluation plan, that is the cheaper place to start — a BEP usually removes tests from a list rather than adding them.
Sensitization: in vitro KeratinoSens®, OECD 442 D (GLP)
KeratinoSens is the in vitro skin sensitization assay for the second key event of the adverse outcome pathway: activation of the Keap1-Nrf2-ARE pathway in keratinocytes.
GRK-4002-03
Sensitization: Magnusson-Kligman Method, 2 extracts (GLP)
The guinea pig maximisation test is the reference animal method for sensitization.
GRP-4002-MK
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