安科生物(300009.SZ):兩項產品獲得第一類醫療器械備案憑證
格隆匯9月18日丨安科生物(300009.SZ)公佈,公司於近日取得合肥市市場監督管理局核發的《第一類醫療器械備案編號吿知書》,產品包括鈣熒光白染色液(CFW)、免疫顯色試劑。上述備案憑證的獲得標誌着公司新產品鈣熒光白染色液(CFW)和免疫顯色試劑獲准上市銷售。
Calconuorwhite(CFW)是一種熒光染料,它與多種植物及真菌胞壁的幾丁質和纖維素有很強的親和力,在一定的長波紫外光下,被CFW染色的真菌會發出很強的亮藍色熒光,主要在皮膚/呼吸科有着廣泛的應用。
相比於傳統的真菌染色方法,鈣熒光白染色液(CFW)有快速檢測、對比鮮明的特點,國外實驗室已將其作為從標本中直接檢測真菌的一種常用方法。免疫顯色試劑採用熒光染色方法和受光顯色原理,對各種臨牀樣本中的脱落細胞進行染色,供臨牀輔助參考。
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