三諾生物(300298.SZ):14項產品近日取得醫療器械註冊證
格隆匯2月21日丨三諾生物(300298.SZ)公佈,公司於近日收到湖南省藥品監督管理局頒發的十四項《醫療器械註冊證》,具體情況如下:
1、N-末端腦鈉肽前體(NT-proBNP)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中N末端腦鈉肽前體(NT-proBNP)的含量;
2、胰島素自身抗體(IAA)檢測試劑盒(化學發光免疫分析法),用於體外定性檢測人體血清或(和)血漿中胰島素自身抗體(IAA);
3、降鈣素原(PCT)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中降鈣素原(PCT)的含量;
4、肌酸激酶同工酶(CKMB)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中肌酸激酶同工酶(CKMB)的含量;
5、白介素-6(IL-6)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中白介素-6(IL-6)的含量;
6、胰島細胞抗體(ICA)檢測試劑盒(化學發光免疫分析法),用於體外定性測定人體血清或(和)血漿中胰島細胞抗體(ICA);
7、酪氨酸磷酸酶(IA-2)抗體檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中酪氨酸磷酸酶(IA-2)抗體的含量;
8、穀氨酸脱羧酶抗體(GAD-Ab)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中谷氨 酸脱羧酶抗體(GAD-Ab)的含量;
9、超敏肌鈣蛋白I(hs-cTnI)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中肌鈣蛋白I(cTnI)的含量;
10、鋅轉運蛋白8(ZnT8)抗體檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中鋅轉運蛋白8(ZnT8)抗體的含量;
11、胰島素(INS)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中胰島素(INS)的含量;
12、D-二聚體(D-Dimer)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血漿中D-二聚體(D-Dimer)的含量;
13、C肽(C-P)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中C肽(C-P)的含量;
14、肌紅蛋白(MYO)檢測試劑盒(化學發光免疫分析法),用於體外定量測定人體血清或(和)血漿中肌紅蛋白(MYO)的含量。
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