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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。
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
