安科生物(300009.SZ):抗繆勒氏管激素檢測試劑盒產品獲醫療器械註冊證(體外診斷試劑)
格隆匯1月7日丨安科生物(300009.SZ)公佈,2020年1月6日,公司取得安徽省藥品監督管理局核發的《醫療器械註冊證(體外診斷試劑)》(註冊證編號:皖械注準20192400206)。該註冊證的獲得標誌着公司的新產品抗繆勒氏管激素(AMH)檢測試劑盒(酶聯免疫法)獲准上市銷售。
此次獲批的抗穆勒氏管激素(AMH)檢測試劑盒(酶聯免疫法)臨牀用於體外定量檢測人血清中抗繆勒氏管激素(AMH)的濃度,包裝規格為96人份/盒。
抗繆勒氏管激素(anti-Mullerian hormone,AMH),是轉化生長因子(TGFβ)超家族的二聚糖蛋白成員,主要由卵巢顆粒細胞分泌,其生理功能是抑制基礎卵泡募集和選擇優勢卵泡,調控卵泡生長和發育。目前,臨牀推薦AMH檢測用於評估女性卵巢儲備功能。
該產品的開發、上市,將進一步豐富公司在女性不育檢測領域的產品線,提升公司診斷試劑產品的市場競爭力,對公司未來的經營將產生積極影響。
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