新產業(300832.SZ):1項試劑新產品取得醫療器械註冊證
格隆匯2月21日丨新產業(300832.SZ)公佈,近日,公司收到了廣東省藥品監督管理局頒發的1項《醫療器械註冊證》。該項目為第二代產品,重新註冊。
產品名稱:穀氨酸脱羧酶抗體測定試劑盒(化學發光免疫分析法);註冊分類:Ⅱ類;註冊證有效期:2023年2月15日-2028年2月14日;適用範圍:用於定量測定人血清或血漿中谷氨酸脱羧酶抗體(Anti-GAD)的含量,臨牀上主要用於Ⅰ型糖尿病的輔助診斷。
穀氨酸脱羧酶抗體(Anti-GAD)是Ⅰ型糖尿病最早出現的免疫學指標,在臨牀症狀出現之前的較長時間即可出現,可從Ⅱ型糖尿病患者中鑑別遲髮型Ⅰ型糖尿病,有助於鑑別Ⅰ型和Ⅱ型糖尿病。
截至目前,公司已先後取得156項化學發光試劑《醫療器械註冊證》(共222個註冊證)。以上試劑新產品醫療器械註冊證的取得,豐富了公司化學發光檢測產品中“糖代謝”項目類別,將對公司發展具有正面影響
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