COVID-19 IVD EUA AUthorization Testing
Project Description
USA OR CANADA LABORATORY
MULTIPLE TESTS
Antigen Test Developers needs FDA GMP analytical laboratory for the following COVID-19 IVD EUA authorization testing:
- Limit of Detection (Analytical Sensitivity)
- Inclusivity (Analytical Reactivity)
- Cross-reactivity (Analytical Specificity)
- Microbial Interference study
- Endogenous/exogenous Interference Substances study
- High-dose Hook Effect study
- Flex studies
Project Information
Number:22-01769
Industry:In-Vitro Diagnostics