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新增29證！熱景生物IVDR累計獲批43個項目，實現(xiàn)四大平臺全覆蓋

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證書由歐洲最有聲望的認(rèn)證機構(gòu)之一英國標(biāo)準(zhǔn)協(xié)會（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際業(yè)務(wù)板塊的產(chǎn)品解決方案，并進一步提升了市場綜合競爭力，為加速拓展國際市場提供了強有力的抓手。

此外，熱景生物本次獲得CE IVDR認(rèn)證的產(chǎn)品還包含維生素、激素等診斷領(lǐng)域的多個小分子夾心法診斷指標(biāo)，標(biāo)志著熱景生物高精度小分子免疫檢測產(chǎn)品的又一階段性新成果。熱景生物獨立研發(fā)的小分子夾心法診斷產(chǎn)品平衡了臨床靈敏度和經(jīng)濟性，為全球小分子診斷提供了新選擇。我們將在這個方向上持續(xù)開發(fā)更多創(chuàng)新產(chǎn)品，及時響應(yīng)市場需求。
“創(chuàng)新診斷，價值檢驗”。秉承“發(fā)展生物科技，造福人類健康”使命，熱景生物將堅持守正創(chuàng)新，為廣大患者和醫(yī)療機構(gòu)提供更多高品質(zhì)診斷試劑和診斷解決方案，為全球醫(yī)療事業(yè)貢獻中國力量，為世界人民健康福祉帶來更大貢獻！

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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