| CXFS1000004 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | New Drug Application | 2011-02-21 | 深圳迈瑞生物医疗电子股份有限公司 | Shenzhen Mindray Bio-Medical Electronics Co Ltd | Certificate Issued | 2012-05-10 | view |
| CXSB0700083 | 梅毒螺旋体抗体诊断试剂盒(化学发光法) | | Diagnostic reagent | IVD | Supplementary Application | 2008-02-18 | 北京科美东雅生物技术有限公司 | Beijing Chemclin Biotech Co Ltd | Certificate Issued | 2008-09-01 | view |
| CXSS0600085 | 梅毒螺旋体抗体诊断试剂盒（双抗原夹心法） | | Diagnostic reagent | IVD | New Drug Application | 2006-09-25 | 北京贝尔生物工程有限公司 | Beijing Beier Bioengineering Co Ltd | Certificate Issued | 2008-02-22 | view |
| CXSS0600093 | 梅毒螺旋体抗体诊断试剂盒（双抗原夹心化学发光法） | | Diagnostic reagent | IVD | New Drug Application | 2006-11-06 | 威海威高生物科技有限公司 | Weihai Weigao BIOTECHNOLOGY Co Ltd | Approval Completed-Pending Certificated | | view |
| CXSS0600121 | 梅毒螺旋体抗体诊断试剂盒（双抗原夹心时间分辨免疫荧光分析法） | | Diagnostic reagent | IVD | New Drug Application | 2006-11-30 | 苏州新波生物技术有限公司 | Suzhou SYM-BIO Life Science Co Ltd;Ruifudi Biomedical (Shanghai) Co Ltd | In Approval | 2008-11-27 | view |
| CXSS2101067 | 梅毒螺旋体抗体诊断试剂盒（磁微粒化学发光法） | | Diagnostic reagent | IVD(2) | New Drug Application | 2021-12-22 | | Suzhou Bacme BIOTECH Co Ltd | | | view |
| CYFB0900059 | 梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-06-13 | 北京万泰生物药业股份有限公司 | Beijing Wantai Biological Pharmacy Enterprise Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYFB1000007 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-06-13 | 北京现代高达生物技术有限责任公司 | Beijing Modern Gaoda Biotechnology Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYFB1000008 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-06-13 | 北京现代高达生物技术有限责任公司 | Beijing Modern Gaoda Biotechnology Co Ltd | Certificate Issued | 2010-11-12 | view |
| CYFB1000015 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-11-19 | 北京华大吉比爱生物技术有限公司 | Beijing BGI-GBI Biotech Co Ltd | In Review | | view |
| CYFB1000025 | 梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-08-25 | 珠海丽珠试剂股份有限公司 | Zhuhai Livzon Diagnostics INC | Certificate Issued | 2010-11-12 | view |
| CYFB1000070 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-12-08 | 潍坊三维生物工程集团有限公司 | Weifang Sanwei Bioengineering Group Co Ltd | Certificate Issued | 2011-03-25 | view |
| CYFB1000083 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2011-03-03 | 北京万泰生物药业股份有限公司 | Beijing Wantai Biological Pharmacy Enterprise Co Ltd | Certificate Issued | 2011-06-10 | view |
| CYFB1100004 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2011-02-10 | 河南华美生物工程有限公司 | Henan Huamei Biological Engineering Co Ltd | Certificate Issued | 2011-12-13 | view |
| CYFB1200066 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2012-07-06 | 珠海丽珠试剂股份有限公司 | Zhuhai Livzon Diagnostics INC | Certificate Issued | 2012-10-30 | view |
| CYFB1300006 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2013-07-22 | 珠海丽珠试剂股份有限公司 | Zhuhai Livzon Diagnostics INC | Certificate Issued | 2013-10-23 | view |
| CYFS0600018 | 梅毒螺旋体抗体诊断试剂盒（酶联免疫法） | | Diagnostic reagent | IVD | Generic Drug | 2006-11-22 | 河北医科大学生物医学工程中心 | Shijiazhuang Kaida Bioengineering Co Ltd | Certificate Issued | 2008-02-22 | view |
| CYSB0500134 | 梅毒螺旋体抗体诊断试剂盒（酶联免疫法） | | Diagnostic reagent | IVD | Supplementary Application | 2005-09-01 | 上海荣盛生物技术有限公司 | Shanghai Rongsheng Biological Pharmaceutical Co Ltd | In Review | 2005-08-30 | view |
| CYSB1000037 | 梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-03-12 | 英科新创（厦门）科技有限公司 | InTec Products INC | Certificate Issued | 2010-07-05 | view |
| CYSB1000052 | 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | | Diagnostic reagent | IVD | Supplementary Application | 2010-10-26 | 北京贝尔生物工程有限公司 | Beijing Beier Bioengineering Co Ltd | In Review | | view |
