CD3检测试剂

上海源奇生物医药科技有限公司

沪奉械备20200040号

上海市奉贤区汇丰西路1817 弄147号2幢2层

2020-03-05

本产品主要成分为CD3单克隆抗体

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。

1、技术要求及说明书中增加产品型号：RV421-1、RV436-1、RV450-1、RV480-1、RV510-1、RV570-1、RV605-1、RV650-1、RV711-1、RV750-1、RV785-1、RV624-1、RV710-1、RV540-1、RV780-1、RV645-1、RV444-1、RV496-1、RV600-1、RV580-1、RV498-1、RV520-1、RV526-1、RV567-1、RV656-1、RV681-1、RV734-1、RV805-1、RB515-1、RB594-1、RB710-1、RB670-1、RB730-1、RB608-1、RB780-1、RB713-1、RB488-1、RB555-1、RB697-1、RR647-1、RR700-1、RR750-1、RR702-1、RR664-1、RR713-1、RR710-1、RR678-1、RR633-1、RB001-1、RB002-1、RB003-1、RB004-1、RB005-1、RB006-1、RB007-1、RR001-1、RR002-1\\r\\n2、变更产品主要组成成分：由含荧光素的CD3单克隆抗体组成。对应荧光素如下：型号RV421-1：荧光素 RV421；型号RV436-1：荧光素RV436；型号RV450-1：荧光素RV450；型号RV480-1：荧光素RV480；型号RV510-1：荧光素RV510；型号RV570-1：荧光素RV570；型号RV605-1：荧光素RV605；型号RV650-1：荧光素RV650；型号RV711-1：荧光素RV711；型号RV750-1：荧光素RV750；型号RV785-1：荧光素RV785；型号RV624-1：荧光素RV624；型号RV710-1：荧光素RV710；型号RV540-1：荧光素RV540；型号RV780-1：荧光素RV780；型号RV645-1：荧光素RV645；型号RV444-1：荧光素RV444；型号RV496-1：荧光素RV496；型号RV600-1：荧光素RV600；型号RV580-1：荧光素RV580；型号RV498-1：荧光素RV498；型号RV520-1：荧光素RV520；型号RV526-1：荧光素RV526；型号RV567-1：荧光素RV567；型号RV656-1：荧光素RV656；型号RV681-1：荧光素RV681；型号RV734-1：荧光素RV734；型号RV805-1：荧光素RV805；型号RB515-1：荧光素RB515；型号RB594-1：荧光素RB594；型号RB710-1：荧光素RB710；型号RB670-1：荧光素RB670；型号RB730-1：荧光素RB730；型号RB608-1：荧光素RB608；型号RB780-1：荧光素RB780；型号RB713-1：荧光素RB713；型号RB488-1：荧光素RB488；型号RB555-1：荧光素RB555；型号RB697-1：荧光素RB697；型号RR647-1：荧光素RR647；型号RR700-1：荧光素RR700；型号RR750-1：荧光素RR750；型号RR702-1：荧光素RR702；型号RR664-1：荧光素RR664；型号RR713-1：荧光素RR713；型号RR710-1：荧光素RR710；型号RR678-1：荧光素RR678；型号RR633-1：荧光素RR633；型号RB001-1：荧光素PerCP；型号RB002-1：荧光素FITC；型号RB003-1：荧光素PE-Cy5；型号RB004-1：荧光素PerCP-Cy5.5；型号RB005-1：荧光素PE-Cy5.5；型号RB006-1：荧光素PE-Cy7；型号RB007-1：荧光素PE；型号RR001-1：荧光素APC-Cy7；型号RR002-1：荧光素APC;2021-06-30,增加试剂准确度的评价方法;2020-10-19,1、产品型号：由“RV421-1、RV436-1、RV450-1、RV480-1、RV510-1、RV570-1、RV605-1、RV650-1、RV711-1、RV750-1、RV785-1、RV624-1、RV710-1、RV540-1、RV780-1、RV645-1、RV444-1、RV496-1、RV600-1、RV580-1、RV498-1、RV520-1、RV526-1、RV567-1、RV656-1、RV681-1、RV734-1、RV805-1、RB515-1、RB594-1、RB710-1、RB670-1、RB730-1、RB608-1、RB780-1、RB713-1、RB488-1、RB555-1、RB697-1、RR647-1、RR700-1、RR750-1、RR702-1、RR664-1、RR713-1、RR710-1、RR678-1、RR633-1、RB001-1、RB002-1、RB003-1、RB004-1、RB005-1、RB006-1、RB007-1、RR001-1、RR002-1 ”变更为“RB001-1、RB002-1、RB003-1、RB004-1、RB005-1、RB006-1、RB007-1、RR001-1、RR002-1、RB488-1、RB515-1、RB555-1、RB594-1、RB608-1、RB610-1、RB670-1、RB697-1、RB710-1、RB713-1、RB730-1、RB780-1、RR633-1、RR647-1、RR664-1、RR678-1、RR700-1、RR702-1、RR710-1、RR713-1、RR750-1、RV421-1、RV436-1、RV444-1、RV450-1、RV480-1、RV496-1、RV498-1、RV501-1、RV510-1、RV520-1、RV526-1、RV540-1、RV550-1、RV567-1、RV570-1、RV580-1、RV600-1、RV605-1、RV624-1、RV645-1、RV650-1、RV656-1、RV681-1、RV710-1、RV711-1、RV734-1、RV750-1、RV780-1、RV785-1、RV805-1、RB740-1、RB708-1；”\\r\\n2、抗体属性：增加“克隆号：UCHT1”，荧光染料由“RV421、RV436、RV450、RV480、RV570、RV605、RV650、RV711、RV750、RV785、RV624、RV710、RV540、RV780、RV645、RV444、RV496、RV600、RV580、RV498、RV520、RV526、RV567、RV656、RV681、RV501、RV734、RV805、RB515、RB594、RB710、RB670、RB730、RB608、RB780、RB713、RB488、RB555、RB697、RR647、RR700、RR750、RR702、RR664、RR713、RR710、RR678、RR633、PerCP、FITC、PE-Cy5、PerCP-Cy5.5、PE-Cy5.5、PE-Cy7、PE、APC-Cy7、APC”变更为“RV421、RV436、RV450、RV480、RV510、RV570、RV605、RV650、RV711、RV750、RV785、RV624、RV710、RV540、RV780、RV645、RV444、RV496、RV600、RV580、RV498、RV520、RV526、RV567、RV656、RV681、RV550、RV501、RV734、RV805、RB515、RB594、RB710、RB670、RB730、RB608、RB780、RB713、RB488、RB555、RB697、RB610、RR647、RR700、RR750、RR702、RR664、RR713、RR710、RR678、RR633、RB740、RB708、PerCP、FITC、PE-Cy5、PerCP-Cy5.5、PE-Cy5.5、PE-Cy7、PE、APC-Cy7、APC”\\r\\n3、储存条件及有效期由“12个月(不能超过标签保质期使用)”变更为“18个月(不能超过标签保质期使用)”\\r\\n4、生产企业由“住所：上海市奉贤区汇丰北路699号4幢2楼 联系方式：021-37196225 生产地址: 上海市奉贤区汇丰北路699号4幢2楼、3幢3楼”变更为“住所：上海市奉贤区汇丰西路1817弄147号2幢2层 联系方式：021-37199020\\r\\n生产地址：上海市奉贤区望园路2066弄5幢3楼；\\r\\n汇丰西路1817 弄147号1幢4层2幢1层（除3个冷库）、2层”\\r\\n5、分装：删除管子类别。;2023-09-21

上海市奉贤区望园路2066弄5幢3楼； 汇丰西路1817 弄147号1幢4层2幢1层（除3个冷库）、2层

12个月

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