Your Source for CORPORATE SOUVENIR
Brand: Hexin
Packaging: 240 boxes per case
Packing: 240sets/carton
#CE Official Website Published Values #
Accuracy: 98.27%
Clinical sensitivity: 96.83%
Clinical specificity: 99.39%
Simple and easy to use, results are available within 15 minutes, convenient, fast and accurate
The product has multiple quality certifications
One of the brands of rapid antigen test kits recognized by the Hong Kong Special Administrative Region Government
Listed on the HSC common list of the European Union
Passed the EU CE certification
Certified by CIBG of the Netherlands
Received regulatory approval for market access in the EU under the In Vitro Diagnostics Directive (IVDD) 98/79/EC
Obtained ISO 13485 medical Device Quality Management system certification
Complies with the ISO 14971 medical device risk management standard
Complies with the ISO 13612:2002 standard for performance evaluation of in vitro diagnostic medical devices
Complies with the ISO 18113 standard for in vitro diagnostic medical devices
It complies with the stability evaluation standard of ISO 23640 for in vitro diagnostic reagents