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2024-09-11
近日，熱景生物在歐盟體外診斷醫(yī)療器械法規(guī)（IVDR）下新增29款診斷產(chǎn)品的CE認(rèn)證。該CE IVDR證書(shū)由歐洲最有聲望的認(rèn)證機(jī)構(gòu)之一英國(guó)標(biāo)準(zhǔn)協(xié)會(huì)（BSI）頒發(fā)。新批準(zhǔn)的29種診斷試劑覆蓋了熱景生物旗下全系列的的免疫檢測(cè)產(chǎn)品，包括化學(xué)發(fā)光、上轉(zhuǎn)發(fā)光、膠體金和酶聯(lián)免疫產(chǎn)品線下的B類和C類試劑。這一成果豐富了公司在國(guó)際業(yè)務(wù)板塊的產(chǎn)品解決方案，并進(jìn)一步提升了市場(chǎng)綜合競(jìng)爭(zhēng)力，為加速拓展國(guó)際市場(chǎng)提供了強(qiáng)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
