聖湘生物(688289.SH):相關產品取得醫療器械註冊證
格隆匯8月8日丨聖湘生物(688289.SH)公佈,公司的產品人MTHFR基因多態性核酸檢測試劑盒(PCR-熒光探針法)於近日收到由國家藥品監督管理局頒發的《醫療器械註冊證》,MTHFR酶(亞甲基四氫葉酸還原酶)在葉酸代謝中起重要作用,C677T多態性會導致MTHFR酶活性降低,從而影響葉酸代謝,進而可能影響妊娠過程。
該產品可用於定性檢測人外周血和口腔拭子樣本中的MTHFR基因C677T基因多態性,輔助臨牀評估亞甲基四氫葉酸還原酶的活性,指導葉酸補充和妊娠期的綜合健康管理,有效預防和減輕與該多態性相關的妊娠併發症,以提高妊娠質量和出生結局,保障母嬰健康。同時,該試劑作為外周血/口腔拭子雙樣本類型產品,能滿足不同醫療機構和臨牀場景需求,為優生優育提供全面、便捷的解決方案。
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