邁克生物(300463.SZ):尿酸測定試劑盒獲醫療器械註冊證書
格隆匯12月25日丨邁克生物(300463.SZ)公佈,公司於近日收到四川省藥品監督管理局頒發的《醫療器械註冊證》,該產品名稱為尿酸測定試劑盒(尿酸酶法),註冊證書編號為川械注準20192400226,有效期至2024年12月16日。
尿酸是反映人體腎臟功能以及代謝性疾病的常見指標,臨牀應用十分廣泛,目前國內絕大多數醫院使用的尿酸測定試劑為尿酸酶法,但該種方法學的檢測結果容易受到樣本中某種藥物的干擾(如臨牀常用的血管保護劑羥苯磺酸鈣、常用止血藥酚磺乙胺)。上述取得註冊證的尿酸測定試劑盒(尿酸酶法)系公司解決藥物干擾性後的二代更新產品,使檢測結果不受樣本中的羥苯磺酸鈣、酚磺乙胺等藥物干擾,提高了檢測準確性,為患者精準治療提供更有力的保障,也增強了公司在生化診斷領域的競爭優勢,同時,公司綜合競爭力與市場拓展能力也將得到進一步提升,對公司未來的經營將產生積極影響。
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