Medica 2010 - November 17-20, 2010, Düsseldorf, Germany
Assay Development Services
- Twenty plus years of experience in assay development, both lateral flow & ELISA based
- Expertise in production of conjugates, including various size gold particles
- Feasibility studies
- Prototype & beta test development
- Full FDA compliance - design plan & design history files prepared
- Laboratory studies - accelerated stability, cross-reactivity, interference, precision
- Analytical sensitivity & specificity studies
- Clinical trial management
- FDA product submissions (510(k) & PMA)
- Expert regulatory guidance on all design & manufacturing issues
- Full turnkey option available: feasibility study to FDA submission
- Small & large scale manufacturing of rapid & ELISA based immunoassays