IVD China this week: Mindray, KHB and Autobio

Mindray’s HCV product have obtained CE IVDR Class D certification

On October 9, Mindray announced that its Hepatitis C Virus Antibody (Anti HCV) assay kit, has recently obtained the Class D certificate under the IVDR regulation. Mindray has become one of the first Chinese medical device manufacturers to obtain IVDR Class D certification under the EU's new in vitro diagnostic medical device regulations.

KHB's HIV product has obtained CE IVDR Class D certification

On September 26, Shanghai Kehua Bio-Engineering Co., Ltd. obtained the CE certificate for the HIV human immunodeficiency virus antibody testing kit (colloidal gold method) in accordance with the IVDR regulations.

KHB is one of the first companies in China to obtain the IVDR CE Class D certificate for rapid diagnostic products. KHB has extensive and close cooperation with non-governmental organizations from multiple countries and regions such as WHO, Clinton Health Access Initiative, UNICEF, UNICEF, USAID, The Global Fund, PFSCM, IDA Foundation, etc. HIV testing kit (Diagnostic kit for HIV (1+2) Antibody (Colloidal Gold) V2) covers over 10 countries in Africa, Southeast Asia, and other regions.

Autobio’s HBsAg Detection Kit has obtained CE IVDR Class D certification

Recently, Autobio’s Hepatitis B Virus Surface Antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully obtained the CE IVDR Class D certification.

Autobio’s Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Magnetic Particle Chemiluminescence Method), the Human Immunodeficiency Virus Antibody and Antigen (p24) Joint Detection Kit (Magnetic Particle Chemiluminescence Method), the Hepatitis C Virus IgG Antibody Detection Kit (Magnetic Particle Chemiluminescence Method), and the Treponema pallidum Antibody Detection Kit (Magnetic Particle Chemiluminescence Method) have all obtained the access into the EU market.