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Immunology

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