Sensitivity: 89%
Specificty: 92%
Packaging options: 1, 3, 5, 10 and 125 packs
FDA product code: NRK
FDA device class: CLASS II (exempt)
EU product classification: Medical Device CLASS I (MDD 93/42/EC)
Canadian device class: CLASS I
Production capacity: ~50 Million units per month
Manufacturing locations: United States and Germany
Data Privacy: No personal information kept on servers