SHANGHAI, Oct. 11, 2023 /PRNewswire/ -- Shanghai Kehua Bio-engineering Co., Ltd ("KHB" or "the Company", Stock code: 002022.SZ), China's leading In Vitro Diagnostic (IVD) company has achieved a significant milestone by becoming the first Chinese company to obtain EU Class D In Vitro Diagnostic Regulation (IVDR) certification for rapid tests. This certification applies to the company's Diagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2 and was issued by TV SD Product Service GmbH, a world-renowned certification and Notified Body (No. 0123) based in the EU. This significant achievement underscores KHB's unwavering commitment to delivering advanced and reliable diagnostic solutions that meet the latest safety, reliability, and effectiveness standards. The company's continuous focus on immune, biochemical, and molecular diagnosis, as well as point-of-care testing (POCT) further highlights its expertise in providing a diverse range of diagnostic products.
The EU classifies IVDs into four risk classes, ranging from Class A (lowest) to Class D (highest). Diagnostic products for HIV antibodies, including KHB's Diagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2, fall under the Class D category, which is subject to the strictest regulations due to the high risk posed by HIV as a widespread, difficult to cure, and highly lethal disease globally. It is challenging for manufacturers and companies outside the EU to obtain IVDR certification, particularly for Class D IVDs. KHB's achievement in this regard is expected to further promote Chinese IVD products in the highly competitive global market.
Early in 2016, KHB's Diagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2 was granted WHO Prequalification, demonstrating the company's capability to provide reliable diagnostic products. Since then, KHB has forged extensive and diverse partnerships with leading NGOs such as the WHO, Clinton Health Access Initiative, UNICEF, UNFPA, USAID, The Global Fund, PFSCM and IDA Foundation, across multiple countries and regions. KHB's Diagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2 is available in several countries and regions, including the US, Switzerland, South Africa, Morocco, and Thailand, with the list continuously expanding.
KHB's achievement in obtaining EU Class D IVDR Certification is a testament to the company's dedication to delivering advanced and reliable IVD solutions in compliance with the latest safety and regulatory standards. With this milestone, KHB is poised to further enhance its products and services to meet the needs of patients and healthcare providers alike, and to maintain its position as a leading IVD company in China.
Shanghai Kehua Bio-engineering Co., Ltd. (KHB, Stock code: 002022.SZ) is an IVD company that boasts a full line of medical diagnostic products, focusing on immune diagnosis, biochemical diagnosis, molecular diagnosis and point-of-care testing (POCT). Since its foundation in 1981, KHB has developed into a high-tech company that integrates R&D, manufacturing and marketing business operations. In 2004, it was listed in the Shenzhen Stock Exchange (SZSE).
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