Regulatory & Research Use Information
MemorAmp’s technology is built on established biosensor science and is being developed with a clear regulatory pathway in mind. This page explains how our current products are labeled and how we are approaching future FDA and global regulatory approvals.
Research Use Only (RUO)
The current MemorAmp test kits and Reader are offered as Research Use Only (RUO) products.
RUO products are:
• Intended for laboratory, investigational, or exploratory use.
• Designed to support research on biomarkers and brain health.
• Not cleared or approved for clinical diagnostic use.
RUO products are not intended for:
• Diagnosing, treating, curing, or preventing any disease.
• Making clinical decisions or changing a patient’s medical care.
If you use MemorAmp products as part of a study or exploratory project, results should be interpreted in the context of research only, and not as a stand-alone medical diagnosis.