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["附件3"]
["6840 免于进行临床试验的体外诊断试剂目录"]
["序号","产品类别","产品分类名称","预期用途","管理类别"]
["001","Ⅱ-1 用于蛋白质检测的试剂","血红蛋白检测试剂","用于检测人体样本中血红蛋白的含量，临床上主要用于各种贫血、失血等的辅助诊断。","Ⅱ"]
["002","Ⅱ-1 用于蛋白质检测的试剂","糖化血红蛋白分析用洗脱液","与糖化血红蛋白分析系统配套使用，用于检测样本中糖化血红蛋白的含量。","Ⅱ"]
["003","Ⅱ-1 用于蛋白质检测的试剂","总蛋白检测试剂","用于检测人体样本中总蛋白的含量，临床上主要用于辅助评价肝脏功能。","Ⅱ"]
["004","Ⅱ-1 用于蛋白质检测的试剂","白蛋白检测试剂","用于检测人体样本中白蛋白的含量，临床上主要用于辅助评价肝脏功能及营养评估等。","Ⅱ"]
["005","Ⅱ-1 用于蛋白质检测的试剂","前白蛋白检测试剂","用于检测人体样本中前白蛋白的含量，临床上主要用于反映肝损害程度及营养评估等。","Ⅱ"]
["006","Ⅱ-1 用于蛋白质检测的试剂","糖化血红蛋白检测试剂","用于检测人体样本中糖化血红蛋白的含量，临床上主要用于糖尿病的辅助诊断和血糖水平的监控。","Ⅱ"]
["007","Ⅱ-1 用于蛋白质检测的试剂","微量白蛋白检测试剂","用于检测人体样本中微量白蛋白含量，临床上主要用于肾脏疾病的辅助诊断。","Ⅱ"]
["008","Ⅱ-1 用于蛋白质检测的试剂","肌红蛋白检测试剂","用于检测人体样本中的肌红蛋白含量，临床上主要用于心肌梗死的辅助诊断。","Ⅱ"]
["009","Ⅱ-1 用于蛋白质检测的试剂","肌钙蛋白I检测试剂","用于检测人体样本中肌钙蛋白I的含量，临床上主要用于心肌梗死的辅助诊断。","Ⅱ"]
["010","Ⅱ-1 用于蛋白质检测的试剂","肌钙蛋白T检测试剂","用于检测人体样本中肌钙蛋白T的含量，临床上主要用于心肌梗死的辅助诊断。","Ⅱ"]
["011","Ⅱ-1 用于蛋白质检测的试剂","心脏型脂肪酸结合蛋白检测试剂","用于检测人体样本中心脏型脂肪酸结合蛋白的含量，临床上主要用于急性心肌梗死辅助诊断。","Ⅱ"]
["012","Ⅱ-1 用于蛋白质检测的试剂","N末端心房利钠肽(NT-proBNP）检测试剂","用于检测人体样本中N末端心房利钠肽前体(NT-proBNP）的含量，临床上主要用于心力衰竭的辅助诊断。","Ⅱ"]
["013","Ⅱ-1 用于蛋白质检测的试剂","B型利钠肽（BNP）检测试剂","用于检测人体样本中B型利钠肽（BNP）的含量，临床上主要用于心力衰竭的辅助诊断。","Ⅱ"]
["014","Ⅱ-1 用于蛋白质检测的试剂","缺血性修饰白蛋白检测试剂","用于检测人体样本中缺血性修饰白蛋白的含量，主要作为心肌缺血标志物之一。","Ⅱ"]
["015","Ⅱ-1 用于蛋白质检测的试剂","C反应蛋白检测试剂","用于检测人体样本中C反应蛋白的含量，C反应蛋白主要作为一种非特异性炎症指标。","Ⅱ"]
["016","Ⅱ-1 用于蛋白质检测的试剂","α1-酸性糖蛋白检测试剂","用于检测人体样本中α1-酸性糖蛋白的含量，主要作为一种非特异性炎症指标。","Ⅱ"]
["017","Ⅱ-1 用于蛋白质检测的试剂","血清淀粉样蛋白A检测试剂","用于检测血清中淀粉样蛋白A的含量，主要作为一种非特异性炎症指标。","Ⅱ"]
["018","Ⅱ-1 用于蛋白质检测的试剂","Ⅲ型胶原检测试剂","用于检测人体样本中Ⅲ型胶原蛋白的含量，临床上主要用于肝纤维化的辅助诊断。","Ⅱ"]
["019","Ⅱ-1 用于蛋白质检测的试剂","Ⅳ型胶原检测试剂","用于检测人体样本中Ⅳ型胶原蛋白的含量，临床上主要用于肝纤维化的辅助诊断。","Ⅱ"]
["020","Ⅱ-1 用于蛋白质检测的试剂","层粘蛋白检测试剂","用于检测人体样本中层粘蛋白的含量，临床上主要用于肝纤维化的辅助诊断。","Ⅱ"]
["021","Ⅱ-1 用于蛋白质检测的试剂","不饱和铁结合力检测试剂","用于检测人体样本的不饱和铁结合力。临床上主要用于贫血、肝功能障碍等由铁代谢异常引起的疾病的辅助诊断。","Ⅱ"]
["022","Ⅱ-1 用于蛋白质检测的试剂","触珠蛋白检测试剂","用于检测人体样本中触珠蛋白（结合珠蛋白）的含量，临床上主要用于血管内溶血性疾病的辅助诊断。","Ⅱ"]
["023","Ⅱ-1 用于蛋白质检测的试剂","脑脊液/尿液总蛋白检测试剂","用于检测脑脊液/尿液样本中总蛋白的含量，临床上主要用于中枢神经系统/肾脏疾病的辅助诊断。","Ⅱ"]
["024","Ⅱ-1 用于蛋白质检测的试剂","视黄醇结合蛋白检测试剂","用于检测人体样本中视黄醇结合蛋白的含量，临床上主要用于肝脏或肾小管损伤性疾病的辅助诊断。","Ⅱ"]
["025","Ⅱ-1 用于蛋白质检测的试剂","转铁蛋白检测试剂","用于检测人体样本中转铁蛋白的含量，临床上主要用于铁缺乏症、肝脏等疾病的辅助诊断。","Ⅱ"]
["026","Ⅱ-1 用于蛋白质检测的试剂","糖化血清蛋白检测试剂","用于检测人体样本中糖化血清蛋白的含量，临床上主要用于血糖水平的监控。","Ⅱ"]
["027","Ⅱ-1 用于蛋白质检测的试剂","糖化血清白蛋白检测试剂","用于检测人体样本中糖化血清白蛋白的含量，临床上主要用于血糖水平的监控。","Ⅱ"]
["028","Ⅱ-1 用于蛋白质检测的试剂","胃蛋白酶原Ⅰ检测试剂","用于检测人体样本中胃蛋白酶原I的含量，临床上主要用于评价胃泌酸腺细胞功能。","Ⅱ"]
["029","Ⅱ-1 用于蛋白质检测的试剂","胃蛋白酶原Ⅱ检测试剂","用于检测人体样本中胃蛋白酶原Ⅱ的含量，临床上主要用于评价胃底粘腺病变。","Ⅱ"]
["030","Ⅱ-1 用于蛋白质检测的试剂","抗链球菌溶血素O检测试剂","用于检测人体样本中抗链球菌溶血素O的含量，临床上主要用于急性风湿热的辅助诊断。","Ⅱ"]
["031","Ⅱ-1 用于蛋白质检测的试剂","降钙素检测试剂","用于检测人体样本中的降钙素(CT)的含量，临床上主要用于甲状旁腺功能的辅助诊断。","Ⅱ"]
["032","Ⅱ-1 用于蛋白质检测的试剂","降钙素原检测试剂","用于检测人体样本中的降钙素原（PCT）的含量，临床上主要用于细菌感染性疾病的辅助诊断。","Ⅱ"]
["033","Ⅱ-1 用于蛋白质检测的试剂","骨钙素检测试剂","用于检测人体样本骨钙素的含量，临床上主要用于各种骨质疏松及骨损伤后骨质合成早期的评价。","Ⅱ"]
["034","Ⅱ-1 用于蛋白质检测的试剂","铁蛋白检测试剂","用于检测人体样本中的铁蛋白的含量，临床上主要用于铁代谢的相关疾病，如血色素沉着症和缺铁性贫血的辅助诊断。","Ⅱ"]
["035","Ⅱ-1 用于蛋白质检测的试剂","α2-巨球蛋白检测试剂","用于检测人体样本中α2-巨球蛋白的含量，临床上主要用于肝、肾疾病的辅助诊断。 ","Ⅱ"]
["036","Ⅱ-1 用于蛋白质检测的试剂","免疫球蛋白检测试剂","用于检测人体样本中免疫球蛋白G/A/M的含量，临床上主要用于免疫功能的评价及免疫疾病的辅助诊断。","Ⅱ"]
["037","Ⅱ-1 用于蛋白质检测的试剂","免疫球蛋白G亚型检测试剂","用于检测人体样本中免疫球蛋白G亚型（如IgG1、IgG2、IgG3、IgG4）的含量，临床上主要用于免疫功能的评价及免疫疾病的辅助诊断。","Ⅱ"]
["038","Ⅱ-1 用于蛋白质检测的试剂","特异性IgG抗体检测试剂","用于检测人体样本中针对食物（如肉类、鱼类，玉米、海鲜、蔬菜）等的特异性IgG抗体水平。","Ⅱ"]
["039","Ⅱ-1 用于蛋白质检测的试剂","可溶性转铁蛋白受体检测试剂","用于检测人体样本中的可溶性转铁蛋白受体 (sTfR) 含量，临床上主要用于缺铁性贫血的辅助诊断。","Ⅱ"]
["040","Ⅱ-1 用于蛋白质检测的试剂","α1-微球蛋白检测试剂","用于检测人体样本中α1-微球蛋白的含量，临床上主要用于用于肾小管损伤的辅助诊断。   ","Ⅱ"]
["041","Ⅱ-1 用于蛋白质检测的试剂","β2-微球蛋白检测试剂","用于检测人体样本中β2-微球蛋白的含量，临床上主要用于监测近端肾小管的功能。","Ⅱ"]
["042","Ⅱ-1 用于蛋白质检测的试剂","胱抑素C检测试剂","用于检测人体样本中胱抑素C的含量，主要作为反映肾小球滤过率的指标之一。","Ⅱ"]
["043","Ⅱ-1 用于蛋白质检测的试剂","中性粒细胞明胶酶相关脂质运载蛋白检测试剂","用于检测人体样本中的中性粒细胞明胶酶相关脂质运载蛋白(NGAL)，临床上主要用于辅助诊断肾功能损伤。","Ⅱ"]
["044","Ⅱ-1 用于蛋白质检测的试剂","妊娠相关血浆蛋白A检测试剂","用于检测人体样本中妊娠相关血浆蛋白A（PAPP-A）的含量，临床上主要用于评估孕前期三个月唐氏综合征的风险。","Ⅱ"]
["045","Ⅱ-1 用于蛋白质检测的试剂","细菌唾液酸酶检测","用于检测阴道分泌物样本中唾液酸酶活性，临床上主要用于细菌性阴道病的辅助诊断。","Ⅱ"]
["046","Ⅱ-1 用于蛋白质检测的试剂","隐血检测试剂","用于检测人体样本中的血红蛋白，临床上主要用于出血性病变的初步检查。","Ⅱ"]
["047","Ⅱ-1 用于蛋白质检测的试剂","大便隐血检测试剂","用于人体粪便样本中血红蛋白的检测，临床上用于评估消化道出血。","Ⅱ"]
["048","Ⅱ-1 用于蛋白质检测的试剂","胰岛素样生长因子结合蛋白检测试剂","用于检测人体样本中的胰岛素样生长因子结合蛋白(I、Ⅲ），临床上主要用于生长紊乱和胎膜早破的辅助诊断。","Ⅱ"]
["049","Ⅱ-1 用于蛋白质检测的试剂","血清组织金属蛋白酶抑制因子I检测试剂","用于检测人体样品中血清组织金属蛋白酶抑制因子I的含量，临床上主要用于肝纤维化的辅助诊断。","Ⅱ"]
["050","Ⅱ-1 用于蛋白质检测的试剂","κ轻链检测试剂","用于检测人体样本（如血清和尿液）中的κ轻链 ，临床上主要用于自身免疫疾病、感染、肝病、肾病等的辅助诊断。","Ⅱ"]
["051","Ⅱ-1 用于蛋白质检测的试剂","λ轻链检测试剂","用于检测人体样本（如血清和尿液）中的λ轻链 ，临床上主要用于自身免疫疾病、感染、肝病、肾病等的辅助诊断。","Ⅱ"]
["052","Ⅱ-2 用于糖类检测的试剂","葡萄糖检测试剂","用于检测人体样本中葡萄糖的含量，临床上主要用于反映血糖水平。","Ⅱ"]
["053","Ⅱ-2 用于糖类检测的试剂","β-羟丁酸检测试剂","用于检测人体样本中β-羟丁酸(D3羟丁酸)的含量，临床上主要用于酮症酸中毒的辅助诊断。","Ⅱ"]
["054","Ⅱ-2 用于糖类检测的试剂","乳酸检测试剂","用于检测人体样本中乳酸的含量，临床上主要用于代谢性酸中毒的辅助诊断。","Ⅱ"]
["055","Ⅱ-2 用于糖类检测的试剂","丙酮酸检测试剂","用于检测人体样本中丙酮酸的含量，临床上主要用于酮症酸中毒的辅助诊断。","Ⅱ"]
["056","Ⅱ-4 用于酶类检测的试剂","丙氨酸氨基转移酶检测试剂","用于检测人体样本中丙氨酸氨基转移酶的活性，临床上主要用于辅助评价肝功能。","Ⅱ"]
["057","Ⅱ-4 用于酶类检测的试剂","天门冬氨酸氨基转移酶检测试剂","用于检测人体样本中天冬氨酸氨基转移酶的活性，临床上主要用于病毒性肝炎、阻塞性黄疸、心肌梗死的辅助诊断。","Ⅱ"]
["058","Ⅱ-4 用于酶类检测的试剂","天门冬氨酸氨基转移酶同工酶检测试剂","用于检测人体样本中天门冬氨酸氨基转移酶同工酶的活性，临床上主要用于毒性肝炎、阻塞性黄疸、心肌梗死的辅助诊断。","Ⅱ"]
["059","Ⅱ-4 用于酶类检测的试剂","碱性磷酸酶检测试剂","用于检测人体样本中碱性磷酸酶的活性，临床上主要用于肝胆疾病和骨骼疾病的辅助诊断。","Ⅱ"]
["060","Ⅱ-4 用于酶类检测的试剂","乳酸脱氢酶检测试剂","用于检测人体样本中乳酸脱氢酶的活性，临床上主要用于心肌梗死、肝病等疾病的辅助诊断。","Ⅱ"]
["061","Ⅱ-4 用于酶类检测的试剂","乳酸脱氢酶同工酶检测试剂","用于检测人体样本中乳酸脱氢酶同工酶的活性，临床上主要用于心肌梗死、肝病等疾病的辅助诊断。","Ⅱ"]
["062","Ⅱ-4 用于酶类检测的试剂","γ-谷氨酰基转移酶检测试剂","用于检测人体样本中γ-谷氨酰基转移酶的活性，临床上主要用于肝胆系统疾病的辅助诊断。","Ⅱ"]
["063","Ⅱ-4 用于酶类检测的试剂","γ-谷氨酰基转移酶同工酶检测试剂","用于检测人体样本中γ-谷氨酰基转移酶同工酶的活性，临床上主要用于肝胆系统疾病的辅助诊断。","Ⅱ"]
["064","Ⅱ-4 用于酶类检测的试剂","肌酸激酶检测试剂","用于检测人体样本中肌酸激酶的活性，临床上主要用于心肌梗死、病毒性心肌炎的辅助诊断。","Ⅱ"]
["065","Ⅱ-4 用于酶类检测的试剂","肌酸激酶同工酶（CKMB）检测试剂","用于检测人体样本中肌酸激酶同工酶的活性，临床上主要用于心肌梗死、肌病等疾病的辅助诊断。","Ⅱ"]
["066","Ⅱ-4 用于酶类检测的试剂","α-淀粉酶检测试剂","用于检测人体样本中α-淀粉酶的活性，临床上主要用于胰腺疾病的辅助诊断。","Ⅱ"]
["067","Ⅱ-4 用于酶类检测的试剂","胆碱脂酶检测试剂","用于检测人体样本中胆碱脂酶的活性，临床上主要用于肝脏损伤及有机磷中毒的辅助诊断。","Ⅱ"]
["068","Ⅱ-4 用于酶类检测的试剂","丁酰胆碱脂酶检测试剂","用于检测人体样本中丁酰胆碱脂酶的活性，临床上主要用于有机磷中毒的辅助诊断。","Ⅱ"]
["069","Ⅱ-4 用于酶类检测的试剂","腺苷脱氨酶检测试剂","用于检测人体样本中腺苷脱氨酶的活性，临床上主要用于辅助评价肝损伤和胸水的鉴别诊断。","Ⅱ"]
["070","Ⅱ-4 用于酶类检测的试剂","脂肪酶检测试剂","用于检测人体样本中脂肪酶的活性，临床上主要用于急性胰腺炎的辅助诊断。","Ⅱ"]
["071","Ⅱ-4 用于酶类检测的试剂","单胺氧化酶检测试剂","用于检测人体样本中单胺氧化酶的活性，临床上主要用于肝纤维化的辅助诊断。","Ⅱ"]
["072","Ⅱ-4 用于酶类检测的试剂","5'-核苷酸酶检测试剂","用于检测人体样本中5'-核苷酸酶的活性，主要用于肝胆系统疾病的辅助诊断。","Ⅱ"]
["073","Ⅱ-4 用于酶类检测的试剂","α-羟丁酸脱氢酶检测试剂","用于检测人体样本中α-羟丁酸脱氢酶的活性，临床上主要用于心肌梗死的辅助诊断。","Ⅱ"]
["074","Ⅱ-4 用于酶类检测的试剂","N-乙酰-β-D-氨基葡萄糖苷酶检测试剂","用于检测人体样本中N-乙酰-β-D-氨基葡萄糖苷酶的活性，临床上主要用于辅助评价肾小管损害。","Ⅱ"]
["075","Ⅱ-4 用于酶类检测的试剂","超氧化物歧化酶检测试剂","用于检测人体样本中超氧化物歧化酶的活性，临床上主要用于辅助评价机体抗氧化能力。","Ⅱ"]
["076","Ⅱ-4 用于酶类检测的试剂","甘氨酰脯氨酸二肽氨基肽酶检测试剂","用于检测人体样本中甘氨酰脯氨酸二肽氨基肽酶的活性，临床上主要用于肝胆疾病、胃肠疾病的辅助诊断。","Ⅱ"]
["077","Ⅱ-4 用于酶类检测的试剂","谷胱甘肽还原酶检测试剂","用于检测人体样本中谷胱甘肽还原酶的活性，临床上主要用于葡萄糖-6磷酸脱氢酶（G-6-PD）缺乏症的辅助诊断。","Ⅱ"]
["078","Ⅱ-4 用于酶类检测的试剂","α1-抗胰蛋白酶检测试剂","用于检测人体样本中的α1- 抗胰蛋白酶（α1- 蛋白酶抑制物）的活性，主要作为非特异性炎症指标之一。","Ⅱ"]
["079","Ⅱ-4 用于酶类检测的试剂","亮氨酸氨基转肽酶检测试剂","用于检测人体样本中亮氨酸氨基转肽酶的活性，临床上主要用于肝、胆疾病的辅助诊断。","Ⅱ"]
["080","Ⅱ-4 用于酶类检测的试剂","醛缩酶检测试剂","用于检测人体样本中醛缩酶的活性，临床上主要用于肝脏等疾病的辅助诊断。","Ⅱ"]
["081","Ⅱ-4 用于酶类检测的试剂","肾素检测试剂","用于检测人体样本中肾素的活性，临床上主要用于肾性高血压、内分泌型高血压的辅助诊断。","Ⅱ"]
["082","Ⅱ-4 用于酶类检测的试剂","血管紧张素转化酶检测试剂","用于检测人体样本中血管紧张素转化酶的活性，临床上主要用于高血压用药监测和结节病的辅助诊断。","Ⅱ"]
["083","Ⅱ-4 用于酶类检测的试剂","胰蛋白酶检测试剂","用于检测人体样本中胰蛋白酶的活性，临床上主要用于胰腺疾病的辅助诊断。","Ⅱ"]
["084","Ⅱ-4 用于酶类检测的试剂","异柠檬酸脱氢酶检测试剂","用于检测人体样本中异柠檬酸脱氢酶的活性，临床上主要用于肝脏疾病的辅助诊断。","Ⅱ"]
["085","Ⅱ-4 用于酶类检测的试剂","髓过氧化物酶检测试剂","用于检测人体样本中髓过氧化物酶（MPO）的活性，临床上用于临床上主要用于心血管系统炎症的辅助诊断。","Ⅱ"]
["086","Ⅱ-5 用于酯类检测的试剂","胆固醇检测试剂","用于检测人体样本中胆固醇的含量，临床上主要用于高胆固醇血症的辅助诊断。","Ⅱ"]
["087","Ⅱ-5 用于酯类检测的试剂","游离胆固醇检测试剂","用于检测人体样本中游离胆固醇的含量，临床上主要用于肝脏疾病的辅助诊断。","Ⅱ"]
["088","Ⅱ-5 用于酯类检测的试剂","甘油三酯检测试剂","用于检测人体样本中甘油三酯的含量，临床上主要用于高甘油三酯血症的辅助诊断。","Ⅱ"]
["089","Ⅱ-5 用于酯类检测的试剂","游离脂肪酸检测试剂","用于检测人体样本中游离脂肪酸的含量，临床上主要用于高脂血症、冠心病和动脉粥样硬化的辅助诊断。","Ⅱ"]
["090","Ⅱ-5 用于酯类检测的试剂","高密度脂蛋白胆固醇检测试剂","用于检测人体样本中高密度脂蛋白胆固醇的含量，临床上主要用于高胆固醇血症、冠心病和动脉粥样硬化的辅助诊断。","Ⅱ"]
["091","Ⅱ-5 用于酯类检测的试剂","低密度脂蛋白胆固醇检测试剂","用于检测人体样本中低密度脂蛋白胆固醇的含量，临床上主要用于高胆固醇血症、冠心病和动脉粥样硬化的辅助诊断。","Ⅱ"]
["092","Ⅱ-5 用于酯类检测的试剂","脂蛋白a检测试剂","用于检测人体样本中载脂蛋白a的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["093","Ⅱ-5 用于酯类检测的试剂","载脂蛋白A1检测试剂","用于检测人体样本中载脂蛋白A1的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["094","Ⅱ-5 用于酯类检测的试剂","载脂蛋白A2检测试剂","用于检测人体样本中载脂蛋白A2的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["095","Ⅱ-5 用于酯类检测的试剂","载脂蛋白B检测试剂","用于检测人体样本中载脂蛋白B的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["096","Ⅱ-5 用于酯类检测的试剂","载脂蛋白C2检测试剂","用于检测人体样本中载脂蛋白C2的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["097","Ⅱ-5 用于酯类检测的试剂","载脂蛋白C3检测试剂","用于检测人体样本中载脂蛋白C3的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["098","Ⅱ-5 用于酯类检测的试剂","载脂蛋白E检测试剂","用于检测人体样本中载脂蛋白E的含量，临床上主要用于评价心血管疾病风险。","Ⅱ"]
["099","Ⅱ-7 用于无机离子检测的试剂","碘检测试剂","用于检测人体样本中碘的含量，临床上主要用于甲状腺疾病的辅助诊断。","Ⅱ"]
["100","Ⅱ-7 用于无机离子检测的试剂","氨检测试剂","用于检测人体样本中氨的含量，临床上主要用于肝性脑病的辅助诊断。","Ⅱ"]
["101","Ⅱ-7 用于无机离子检测的试剂","氯检测试剂","用于检测人体样本中氯的含量，临床上主要用于高氯血症或低氯血症的辅助诊断。","Ⅱ"]
["102","Ⅱ-7 用于无机离子检测的试剂","二氧化碳检测试剂","用于检测人体样本中二氧化碳的含量，临床上主要作为体内酸碱平衡的评价指标。","Ⅱ"]
["103","Ⅱ-7 用于无机离子检测的试剂","汞检测试剂","用于检测人体样本中汞的含量，临床上主要用于汞中毒的辅助诊断。","Ⅱ"]
["104","Ⅱ-7 用于无机离子检测的试剂","锂检测试剂","用于检测人体样本中锂的含量，临床上主要用于锂盐中毒的辅助诊断。","Ⅱ"]
["105","Ⅱ-7 用于无机离子检测的试剂","钙检测试剂","用于检测人体样本中钙离子的含量，临床上主要用于钙代谢紊乱的辅助诊断。","Ⅱ"]
["106","Ⅱ-7 用于无机离子检测的试剂","铜检测试剂","用于检测人体样本中铜离子的含量，临床上主要用于铜代谢紊乱的辅助诊断。","Ⅱ"]
["107","Ⅱ-7 用于无机离子检测的试剂","钾检测试剂","用于检测人体样本中钾离子的含量，临床上主要用于钾代谢紊乱的辅助诊断。","Ⅱ"]
["108","Ⅱ-7 用于无机离子检测的试剂","镁检测试剂","用于检测人体样本中镁离子的含量，临床上主要用于镁代谢紊乱的辅助诊断。","Ⅱ"]
["109","Ⅱ-7 用于无机离子检测的试剂","钠检测试剂","用于检测人体样本中钠离子的含量，临床上主要用于钠代谢紊乱的辅助诊断。","Ⅱ"]
["110","Ⅱ-7 用于无机离子检测的试剂","磷检测试剂","用于检测人体样本中磷的含量，临床上主要用于磷代谢紊乱的辅助诊断。","Ⅱ"]
["111","Ⅱ-7 用于无机离子检测的试剂","锌检测试剂","用于检测人体样本中锌离子的含量，临床上主要用于锌代谢紊乱的辅助诊断。","Ⅱ"]
["112","Ⅱ-7 用于无机离子检测的试剂","铁检测试剂","用于检测人体样本中铁离子的含量，临床上主要用于贫血的辅助诊断。","Ⅱ"]
["113","Ⅱ-7 用于无机离子检测的试剂","总铁结合力检测试剂","用于检测人体样本的总铁结合力，临床上主要用于贫血的辅助诊断。","Ⅱ"]
["114","Ⅱ-11 用于其他生理、生化或免疫功能指标检测的试剂","肌酐检测试剂","用于检测人体样本中肌酐的含量，临床上主要作为肾功能的评价指标之一。","Ⅱ"]
["115","Ⅱ-11 用于其他生理、生化或免疫功能指标检测的试剂","尿酸检测试剂","用于检测人体样本中尿酸的含量，临床上主要用于高尿酸血症的辅助诊断。","Ⅱ"]
["116","Ⅱ-11 用于其他生理、生化或免疫功能指标检测的试剂","尿素检测试剂","该产品用于体外定量测定人体样本中尿素的含量，临床上主要作为肾功能的评价指标之一。","Ⅱ"]