KHB Becomes First Chinese Company to Obtain EU Class D IVDR Certification for Its Rapid Test HIV Colloidal Gold Diagnostic Kit
KHB Becomes First Chinese Company to Obtain EU Class D IVDR Certification for Its Rapid Test HIV Colloidal Gold Diagnostic Kit
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 TÜV SÜD 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.
上海，2023年10月11日/美通社/--上海科華生物工程有限公司(“KHB”或“公司”，股票代碼：002022.SZ)，中國領先的體外診斷(IVD)公司成為首家獲得歐盟D類快速檢測診斷法規(IVDR)認證的中國公司，取得了一個重要的里程碑。該認證適用於該公司的愛滋病毒(1/2)抗體(膠體金)V2診斷試劑盒，由總部設在歐盟的世界知名認證和通知機構TÜV SüD產品服務有限公司頒發(編號0123)。這一重大成就突顯了KHB堅定不移地致力於提供先進可靠的診斷解決方案，以滿足最新的安全性、可靠性和有效性標準。該公司繼續專注於免疫、生化和分子診斷，以及護理點檢測(POCT)，進一步突出了其在提供各種診斷產品方面的專業知識。
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.
歐盟將靜脈輸液障礙分為四個風險等級，從A類(最低)到D類(最高)不等。愛滋病毒抗體診斷產品，包括KHB的愛滋病毒(1/2)抗體(膠體金色)V2診斷試劑盒，屬於D類，由於愛滋病毒是一種在全球範圍內普遍存在、難以治癒和高度致命的疾病，因此受到最嚴格的監管。對於歐盟以外的製造商和公司來說，獲得IVDR認證是一項挑戰，特別是對於D類IVD。KHB在這方面的成就有望在競爭激烈的全球市場上進一步推廣中國的IVD產品。
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.
2016年初，KHB的HIV(1/2)抗體(膠體金)V2診斷試劑盒獲得世衛組織資格預審，表明該公司有能力提供可靠的診斷產品。從那時起，KHB在多個國家和地區與世界衛生組織、克林頓衛生服務倡議、聯合國兒童基金會、聯合國人口基金、美國國際開發署、全球基金、公共衛生合作夥伴關係和國際開發協會基金會等主要非政府組織建立了廣泛多樣的夥伴關係。KHB的HIV(1/2)抗體(膠體金)V2診斷試劑盒在幾個國家和地區上市，包括美國、瑞士，南非，莫耳洛哥，以及泰國，隨著名單的不斷擴大。
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.
KHB在獲得歐盟D類IVDR認證方面的成就證明瞭該公司致力於提供符合最新安全和監管標準的先進和可靠的IVD解決方案。隨著這一裡程碑的到來，KHB準備進一步提升其產品和服務，以滿足患者和醫療保健提供者的需求，並保持其作為IVD公司的領先地位中國。
About KHB
關於KHB
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).
上海科華生物-工程有限公司(KHB，股票代碼：002022.SZ)是一家IVD公司，擁有全線醫療診斷產品，專注於免疫診斷、生化診斷、分子診斷和護理點檢測(POCT)。自1981年成立以來，KHB已發展成為一家集研發、製造和營銷業務於一體的高科技公司。2004年，在深圳證券交易所(SZSE)上市。
For more information, please visit KHB's official website and its LinkedIn, Facebook, and Twitter pages.
欲瞭解更多資訊，請訪問KHB的官方網站及其LinkedIn、Facebook和Twitter頁面。
For product or corporate information inquiries may be directed to international@skhb.com.
如需瞭解產品或公司資訊，請發送電子郵件至International@skhb.com。
譯文內容由第三人軟體翻譯。