| 注册证编号 | 湘械注准20222401390 [查看相关产品信息] |
| 注册人名称 | 湖南奥的特生物科技有限公司[查看公司信息] |
| 注册人住所 | 湖南省津市市高新区中小企业孵化园11栋 |
| 生产地址 | 湖南省津市市高新区中小企业孵化园11栋 |
| 产品名称 | 类风湿因子检测试剂盒（免疫比浊法） |
| 管理类别 | 第二类 |
| 型号规格 | R1:30ml×4;R2:30ml×1;R1:36ml×2;R2:9ml×2;R1:36ml×4;R2:9ml×4;R1:60ml×1;R2:15ml×1;R1:60ml×2;R2:15ml×2;R1:60ml×2;R2:30ml×1;R1:60ml×4;R2:15ml×4;R1:60ml×4;R2:30ml×2;R1:60ml×4;R2:60ml×1;R1:60ml×8;R2:15ml×8;R1:60ml×8;R2:60ml×2;R1:80ml×1;R2:20ml×1;R1:80ml×2;R2:20ml×2;R1:80ml×3;R2:20ml×3;R1:80ml×3;R2:60ml×1;R1:80ml×4;R2:20ml×4;R1:80ml×4;R2:80ml×1;R1:80ml×6;R2:20ml×6;R1:80ml×6;R2:60ml×2;R1:80ml×8;R2:20ml×8;R1:80ml×8;R2:80ml×2;R1:48ml×1;R2:12ml×1;R1:48ml×2;R2:24ml×1;R1:48ml×2;R2:12ml×2;R1:48ml×3;R2:12ml×3;R1:48ml×3;R2:36ml×1;R1:72ml×2;R2:36ml×1;R1:48ml×4;R2:24ml×2;R1:48ml×4;R2:48ml×1;R1:72ml×4;R2:72ml×1;R1:48ml×8;R2:12ml×8;R1:48ml×8;R2:24ml×4;R1:48ml×8;R2:48ml×2;R1:30ml×4;R2:15ml×2;R1:24ml×4;R2:6ml×4;R1:28ml×4;R2:7ml×4; 50×1测试;8×60测试;16×60测试;200测试×1;200测试×2。 |
| 结构及组成/主要组成成分 | RF试剂盒由两个组分组成，不同批号试剂盒中的组分不可互换。R1:三羟甲基氨基甲烷缓冲液:100mmol/L(pH7.0)；R2：三羟甲基氨基甲烷缓冲液：100mmol/L(pH7.0)，类风湿因子(RF)致敏胶乳:5％。 |
| 适用范围/预期用途 | 用于体外定量测定人血清中类风湿因子(RF)的含量。 |
| 审批部门 | 湖南省药品监督管理局 |
| 批准日期 | 2022/7/28 |
| 生效日期 | 2022/7/28 |
| 有效期至 | 2027/7/27 |
