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["附件1"]
["流式细胞仪配套用体外诊断试剂分类调整产品清单"]
["序号","产品名称","预期用途","管理类别"]
[1,"CD19检测试剂","检测人体骨髓细胞中CD19的表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[2,"CD20检测试剂","检测人体生物标本中CD20的表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[3,"CD22检测试剂","检测人体生物标本中CD22的表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[4,"CD34检测试剂","用于造血干细胞检测和白血病分型。","Ⅲ"]
[5,"CD138检测试剂","检测人体生物标本中CD138的表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[6,"HLA-B27检测试剂","检测人体生物样本中HLA-B27抗原表达，用于辅助诊断强直性脊柱炎（AS）、Reiter's综合征等疾病。","Ⅲ"]
[7,"Kappa检测试剂","检测人体生物标本中膜轻链表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[8,"Lambda检测试剂","用于白血病和淋巴瘤分析。","Ⅲ"]
[9,"造血干细胞计数试剂","检测人体生物标本中CD34的表达，用于CD34+细胞相对计数及绝对计数，及血液肿瘤辅助诊断。","Ⅲ"]
[10,"CD3/CD4检测试剂盒","检测人体生物标本中CD3，CD4的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[11,"CD3/CD8检测试剂盒","检测人体生物标本中CD3，CD8的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[12,"CD3/CD19检测试剂盒","检测人体生物标本中CD3，CD19的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ "]
[13,"CD3/CD56检测试剂盒","检测人体生物标本中CD3，CD56的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[14,"CD3/HLA-DR检测试剂盒","检测人体生物标本中CD3的表达，用于白血病和淋巴瘤分析，淋巴细胞分析。","Ⅲ"]
[15,"CD4/CD8检测试剂盒","检测人体生物标本中CD4，CD8的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[16,"CD4/CD29检测试剂盒","检测人体生物标本中CD4，CD29的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[17,"CD4/CD45RA检测试剂盒","检测人体生物标本中CD4，CD45RA的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[18,"CD8/CD56检测试剂盒","检测人体生物标本中CD8，CD56的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[19,"CD14/CD45检测试剂盒","检测人体生物标本中CD14的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[20,"CD3/CD4/CD8检测试剂盒","检测人体生物标本中CD8，CD4，CD3的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[21,"CD3/CD4/CD45检测试剂盒","检测人体生物标本中CD3，CD4的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ "]
[22,"CD3/CD8/CD45检测试剂盒","检测人体生物标本中CD3，CD8的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。可识别和确定红细胞被裂解的全血中人类成熟T淋巴细胞（CD3+）和抑制性/细胞毒性（CD3+CD8+）T淋巴细胞亚群的百分比和绝对计数。","Ⅲ"]
[23,"CD3/CD16/CD56检测试剂盒","检测人体生物标本中CD3，CD15，CD56的表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[24,"CD3/CD19/CD45检测试剂盒","检测人体生物标本中CD3，CD19的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ "]
[25,"CD3/CD56/CD45检测试剂盒","检测人体生物标本中CD45，56，3的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[26,"CD34/CD117/CD45检测试剂盒","检测人体生物标本中CD34，CD117的表达，用于白血病和淋巴瘤分析。","Ⅲ"]
[27,"CD3/CD4/CD8/CD45检测试剂盒","检测人体生物标本中CD3，CD4，CD8的表达，用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ"]
[28,"CD3/CD16/CD56/CD19/CD45检测试剂盒","用于白血病和淋巴瘤分析，淋巴亚群分析。","Ⅲ "]
[29,"CD3/CD4/CD8/CD16/CD56/CD19检测试剂盒","检测红细胞裂解的全血样本中下述成熟淋巴细胞亚群（不含未成熟细胞）的比例：T淋巴细胞（CD3+），B淋巴细胞（CD19+），辅助/诱导T淋巴细胞（CD3+CD4+），抑制/细胞毒T淋巴细胞（CD3+CD8+），自然杀伤细胞（NK）（CD3-CD16+和/或CD56+）。辅助/抑制T淋巴细胞的比例确定。 用于免疫缺陷疾病；自身免疫性疾病；淋巴细胞亚群检测。","Ⅲ"]
[30,"CD3/CD4/CD8/CD16/CD56/CD19/CD45检测试剂盒","6色直接免疫荧光试剂，鉴别和确定外周血中T淋巴细胞、B淋巴细胞和自然杀伤细胞(NK)以及T细胞的CD4+和CD8+亚群的百分比和绝对计数值。用于白血病和淋巴瘤分析，淋巴亚群分析，用于免疫监测、治疗。","Ⅲ"]
[31,"CD3/CD19/CD45/CD56\n检测试剂盒","检测人体生物标本中CD56，CD19，CD3的表达，用于淋巴亚群分析。","Ⅲ "]
[32,"HER-2/NEU检测试剂盒","检测人体生物标本中HER-2/NEU的表达，用于指导临床治疗和用药。","Ⅲ"]
[33,"HLA-B27/HLA-B7检测试剂盒","检测人体生物标本中B27，HLA-B7，的表达，用于强直性脊柱炎（AS）B27抗原检测。","Ⅲ"]
[34,"HLA-DR/DP/DQ检测试剂盒","检测人体生物标本中HLADR，DP，DQ的表达，用于HLA主要组织相容性抗原检测。","Ⅲ"]
[35,"网织红细胞计数质控微球","流式细胞仪校准试剂，检测网织红细胞质控，用于贫血辅助诊断。","Ⅱ"]
[36,"荧光定量微球","流式细胞仪校准试剂，检测每个细胞上的荧光分子量，进而换算成每个细胞上的抗体量。","Ⅱ"]
[37,"荧光补偿试剂","流式细胞仪校准试剂，补偿抗体，用于多色方案设置。","Ⅱ"]
[38,"造血干细胞荧光补偿试剂","流式细胞仪校准试剂，造血干细胞检测补偿试剂，用于方案设置。","Ⅱ"]
[39,"荧光补偿设置微球","流式细胞仪校准试剂，设置荧光补偿，检查仪器灵敏度，用于调整仪器设置。","Ⅱ"]
[40,"绝对计数管","流式细胞仪校准试剂，用于测量血液中白细胞的绝对计数。","Ⅱ"]
[41,"绝对计数荧光微球","流式细胞仪校准试剂，用于确定生物标本中的细胞群的绝对计数。","Ⅱ"]
[42,"CD1a检测试剂","检测人体生物标本中CD1a的表达，为医师提供诊断的辅助信息。","I"]
[43,"CD2检测试剂","检测人体生物标本中CD2的表达，为医师提供诊断的辅助信息。","I"]
[44,"CD3检测试剂","检测人体生物标本中CD3的表达，为医师提供诊断的辅助信息。","I"]
[45,"CD4检测试剂","检测人体生物标本中CD4的表达，为医师提供诊断的辅助信息。","I"]
[46,"CD5检测试剂","检测人体生物标本中CD5的表达，为医师提供诊断的辅助信息。","I"]
[47,"CD7检测试剂","检测人体生物标本中CD7的表达，为医师提供诊断的辅助信息。","I"]
[48,"CD8检测试剂","检测人体生物标本中CD8的表达，为医师提供诊断的辅助信息。","I"]
[49,"CD10检测试剂","检测人体生物标本中CD10的表达，为医师提供诊断的辅助信息。","I"]
[50,"CD11b检测试剂","检测人体生物标本中CD11b的表达，为医师提供诊断的辅助信息。","I"]
[51,"CD11c检测试剂","检测人体生物标本中CD11c的表达，为医师提供诊断的辅助信息。","I"]
[52,"CD13检测试剂","检测人体生物标本中CD13的表达，为医师提供诊断的辅助信息。","I"]
[53,"CD14检测试剂","检测人体生物标本中CD14的表达，为医师提供诊断的辅助信息。","I"]
[54,"CD15检测试剂","检测人体生物标本中CD15的表达，为医师提供诊断的辅助信息。","I"]
[55,"CD16检测试剂","检测人体生物标本中CD16的表达，为医师提供诊断的辅助信息。","I"]
[56,"CD23检测试剂","检测人体生物标本中CD23的表达，为医师提供诊断的辅助信息。","I"]
[57,"CD25检测试剂","检测人体生物标本中CD25的表达，为医师提供诊断的辅助信息。","I"]
[58,"CD33检测试剂","检测人体生物标本中CD33的表达，为医师提供诊断的辅助信息。","I"]
[59,"CD36检测试剂","检测人体生物标本中CD36的表达，为医师提供诊断的辅助信息。","I"]
[60,"CD38检测试剂","检测人体生物标本中CD38的表达，为医师提供诊断的辅助信息。","I"]
[61,"CD45RA检测试剂","检测人体生物标本中CD45RA的表达，为医师提供诊断的辅助信息。","I"]
[62,"CD45RO检测试剂","检测人体生物标本中CD45RO的表达，为医师提供诊断的辅助信息。","I"]
[63,"CD45检测试剂","检测人体生物标本中CD45的表达，为医师提供诊断的辅助信息。","I"]
[64,"CD55检测试剂","检测人体生物标本中CD55的表达，为医师提供诊断的辅助信息。","I"]
[65,"CD56检测试剂","检测人体生物标本中CD56的表达，为医师提供诊断的辅助信息。","I"]
[66,"CD57检测试剂","检测人体生物标本中CD57的表达，为医师提供诊断的辅助信息。","I"]
[67,"CD59检测试剂","检测人体生物标本中CD59的表达，为医师提供诊断的辅助信息。","I"]
[68,"CD62P检测试剂","检测人体生物标本中CD62P的表达，为医师提供诊断的辅助信息。","I"]
[69,"CD69检测试剂","检测人体生物标本中CD69的表达，为医师提供诊断的辅助信息。","I"]
[70,"CD71检测试剂","检测人体生物标本中CD71的表达，为医师提供诊断的辅助信息。","I"]
[71,"CD79a检测试剂","检测人体生物标本中CD79a的表达，为医师提供诊断的辅助信息。","I"]
[72,"CD79b检测试剂","检测人体生物标本中CD79b的表达，为医师提供诊断的辅助信息。","I"]
[73,"CD103检测试剂","检测人体生物标本中CD103的表达，为医师提供诊断的辅助信息。","I"]
[74,"CD117检测试剂","检测人体生物标本中CD117的表达，为医师提供诊断的辅助信息。","I"]
[75,"CD127检测试剂","检测人体生物标本中CD127的表达，为医师提供诊断的辅助信息。","I"]
[76,"FMC7检测试剂              ","检测人体生物标本中FMC7的表达，为医师提供诊断的辅助信息。","I"]
[77,"FoxP3检测试剂","检测人体生物标本中FoxP3的表达，为医师提供诊断的辅助信息。","I"]
[78,"HLA-DR检测试剂","检测人体生物标本中HLA-DR的表达，为医师提供诊断的辅助信息。","I"]
[79,"IFN-α检测试剂","检测人体生物标本中IFN-α的表达，为医师提供诊断的辅助信息。","I"]
[80,"IFN-γ检测试剂","检测人体生物标本中IFN-γ的表达，为医师提供诊断的辅助信息。","I"]
[81,"IL-1β检测试剂","检测人体生物标本中IL-1β的表达，为医师提供诊断的辅助信息。","I"]
[82,"IL-2检测试剂","检测人体生物标本中IL-2的表达，为医师提供诊断的辅助信息。","I"]
[83,"IL-4检测试剂","检测人体生物标本中IL-4的表达，为医师提供诊断的辅助信息。","I"]
[84,"IL-5检测试剂","检测人体生物标本中IL-5的表达，为医师提供诊断的辅助信息。","I"]
[85,"IL-6检测试剂","检测人体生物标本中IL-6的表达，为医师提供诊断的辅助信息。","I"]
[86,"IL-8检测试剂","检测人体生物标本中IL-8的表达，为医师提供诊断的辅助信息。","I"]
[87,"IL-10检测试剂","检测人体生物标本中IL-10的表达，为医师提供诊断的辅助信息。","I"]
[88,"IL-12p70检测试剂","检测人体生物标本中IL-12p70的表达，为医师提供诊断的辅助信息。","I"]
[89,"IL-17检测试剂","检测人体生物标本中IL-17的表达，为医师提供诊断的辅助信息。","I"]
[90,"TdT检测试剂","检测人体生物标本中TdT的表达，为医师提供诊断的辅助信息。","I"]
[91,"TNFα检测试剂","检测人体生物标本中TNFα的表达，为医师提供诊断的辅助信息。","I"]
[92,"ZAP-70检测试剂","检测人体生物标本中ZAP-70的表达，为医师提供诊断的辅助信息。","I"]
[93,"髓过氧化物酶（MPO）检测试剂","检测人体生物标本中MPO的表达，为医师提供诊断的辅助信息。","I"]
[94,"胎儿红细胞检测试剂","检测外周血中胎儿红细胞的存在，为医师提供诊断的辅助信息。","I"]
[95,"网织红细胞计数试剂","检测外周血中的网织红细胞，为医师提供诊断的辅助信息。","I"]
[96,"细胞角蛋白检测试剂","检测人体生物标本中细胞角蛋白的表达，为医师提供诊断的辅助信息。","I"]
[97,"BFA刺激剂","与流式细胞仪配合使用样本处理试剂。蛋白转运抑制剂，阻断淋巴细胞胞内蛋白运输途径，增加细胞因子和/或蛋白在高尔基体中积累，用于细胞因子生成细胞的检测。","I"]
[98,"磁珠稀释液","与流式细胞仪配合使用运行试剂，用于稀释磁珠。","I"]
[99,"固定剂","与流式细胞仪配合使用固定剂，用于检测时细胞固定。","I"]
[100,"免洗溶血素","与流式细胞仪配合使用溶血素，用于溶血。","I"]
[101,"破膜剂","与流式细胞仪配合使用样本处理试剂，用于细胞固定及破膜，以进行胞内细胞因子或蛋白染色。","I"]
[102,"鞘液","与流式细胞仪配合使用流动相，用于使细胞成为单细胞悬液。","I"]
[103,"溶血素","与流式细胞仪配合使用溶血素，用于溶血。","I"]
[104,"同型对照抗体（IgE）","对照抗体，用于方案设置。","I"]
[105,"同型对照抗体（IgG1）","对照抗体，用于方案设置。","I"]
[106,"同型对照抗体（IgG2a）","对照抗体，用于方案设置。","I"]
[107,"同型对照抗体（IgG2b）","对照抗体，用于方案设置。","I"]
[108,"同型对照抗体（IgM）","对照抗体，用于方案设置。","I"]
[109,"同型对照抗体（IgG1/IgG1）","对照抗体，用于多色方案设置。","I"]
[110,"同型对照抗体（IgG1/IgG1/IgG1）","对照抗体，用于多色方案设置。","I"]
[111,"同型对照抗体（IgG1/IgG1/CD45）","对照抗体，用于多色方案设置。","I"]
[112,"同型对照抗体（IgG1/IgG2）","对照抗体，用于方案设置。","I"]
[113,"同型对照抗体（IgG1/IgG2a）","对照抗体，用于方案设置。","I"]
[114,"同型对照抗体（IgG1/IgM）","对照抗体，用于方案设置。","I"]
[115,"同型对照抗体（小鼠IgG1） ","对照抗体，用于方案设置。","I"]
[]
[116,"同型对照抗体（小鼠IgG2A）              ","对照抗体，用于方案设置。","I"]
[117,"同型对照抗体\n（小鼠IgG1血小板）     ","对照抗体，用于方案设置。","I"]

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