2023-09-28
KHB has just obtained the CE certificate for the Diagnostic Kit for HIV(1+2) Antibody (Colloidal Gold) V2, issued by TüV SüD Product Service GmbH, a globally renowned third-party endorsement organization of the EU, in accordance with IVDR regulations.
This significant achievement marks that KHB has become the first Chinese enterprise to obtain the IVDR CE certificate of Class D high-risk rapid diagnostic product, which will promote Chinese high-risk IVD products to step further into the international market.
In the meantime, KHB develops extensive and diverse cooperation with NGOs as WHO, Clinton Health Access Initiative, UNICEF, UNFPA, USAID, The Global Fund, PFSCM and IDA Foundation etc. in many countries and regions. Our Diagnostic kit for HIV(1+2) Antibody (Colloidal Gold) V2 has covered countries and regions in the US, Switzerland, South Africa, Morocco, and Thailand etc., and it’s still on the increase.