Both the cassettes and the AFS-1000 reader are both CE marked as in vitro diagnostic medical devices under the IVDD 98/79/EC.
Regulatory approvals for Italy, Germany, Turkey, Colombia, Honduras, Dominican Republic. FDA EUA and authorisation by Health Canada under the Medical Devices Regulations are pending.
Cassette Storage and Stability
Keep in a cool, dry place. When stored between 2-30 ℃ the cassette remains valid for 18 months. Do not freeze.
The excitation frequency of the device is 475nm and the fluorescence emission from the region of interest of the LFIA test strip is 525nm.
Dimensions and Weight
The AFS-1000 are 300mm x 215mm x 150mm. Weight is 2.5 kg. Suitable for use in both point of care / need and laboratory settings.
Built-in printer supports automatic printing of test reports. Built-in 4G, USB2.0, RS232C, Wi-Fi, Ethernet, LIS, HIS. 7 inches 24 bits colour touch screen. 4D scanner.