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新增29证!热景生物IVDR累计获批43个项目,实现四大平台全覆盖
2024-09-11

近日,热景生物在欧盟体外诊断医疗器械法规(IVDR)下新增29款诊断产品的CE认证。该CE IVDR证书由欧洲最有声望的认证机构之一英国标准协会(BSI)颁发。新批准的29种诊断试剂覆盖了热景生物旗下全系列的的免疫检测产品,包括化学发光、上转发光、胶体金和酶联免疫产品线下的B类和C类试剂。这一成果丰富了公司在国际业务板块的产品解决方案,并进一步提升了市场综合竞争力,为加速拓展国际市场提供了强有力的抓手。


此外,热景生物本次获得CE IVDR认证的产品还包含维生素、激素等诊断领域的多个小分子夹心法诊断指标,标志着热景生物高精度小分子免疫检测产品的又一阶段性新成果。热景生物独立研发的小分子夹心法诊断产品平衡了临床灵敏度和经济性,为全球小分子诊断提供了新选择。我们将在这个方向上持续开发更多创新产品,及时响应市场需求。
“创新诊断,价值检验”。秉承“发展生物科技,造福人类健康”使命,热景生物将坚持守正创新,为广大患者和医疗机构提供更多高品质诊断试剂和诊断解决方案,为全球医疗事业贡献中国力量,为世界人民健康福祉带来更大贡献!


Better for more! 29 More Hotgen Immunoassays Approved under IVDR


Recently, Hotgen adds more diagnostic products under its CE IVDR Certificate. Reviewed by BSI, one of the most reputable notified bodies for CE certifications of medical devices, the newly approved 29 reagents cover a wide spectrum of immunoassays, ranging from chemiluminescence, fluorescence (up-converting phosphor technology, UPT), lateral flow immunochromatography to ELISA, involving both class B and C reagents.


The Regulation (EU) 2017/746 (IVDR) is the new EU legislation for in-vitro diagnostic (IVD) medical devices. On May 26th, 2022, it fully applies across the European Union region. Under this stringent system, the 29 newly certified products include cardiac, hormones, inflammation, and cancer markers. This is an reiteration of Hotgen’s unwavering commitment to safety, quality, and effectiveness of diagnostic products, as well as loyalty to the demand of healthcare professionals and patients.


Meanwhile, this is also the first CE IVDR certificate granted to small-molecule sandwich method diagnostics on mono-test CLIA and fluorescence platforms. It marks a new milestone in Hotgen’s endeavor to promote high-precision immunoassays in the international market. Hotgen’s innovative sandwich method balances both precision and economic viability in the diagnostics of small molecules such as vitamin and hormones. We will keep offering more innovative diagnostic products in this direction, answering the expectation of the market.


Recognized and accepted by over 10,000 medical institutions worldwide as a choice of precision, economy, and flexibility, Hotgen will continue researching, registering, and supplying high-quality precision diagnostic products. We are fully confident in having more Hotgen products registered and recognized in the EU and around the world in near future.

#Hotgen #IVDR #CE #mono-test CLIA #FIA #UPT #CG #ELISA #Innovate diagnostics for value creation

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