List of Prioritized Devices Approved to Enter Green Channel Registration (Continuously updated)

jmedtec0
Index产品名称Product Name申请人License HolderWebsite of LHReason Issue
31非衍生化多种新生儿遗传代谢病筛查试剂盒（串联质谱法） Assay for non-derivatized multiple neonatal genetic metabolic diseases screening (tandem mass spectrometry)苏州新波生物技术有限公司Suzhou Sym Biowww.sym-bio.com.cnRare Diseases2019 No.9
30乙型肝炎病毒pgRNA(HBV-pgRNA)测定试剂盒（PCR-荧光探针法）Assay for hepatitis B virus pgRNA (HBV-pgRNA) (PCR-fluorescence probe method)北京热景生物技术股份有限公司Beijing Hotgenwww.hotgen.com.cnNational Technology Plan2019 No.8
29呼吸道病原菌核酸检测试剂盒（恒温扩增芯片法）Assay for respiratory pathogen nucleic acid (constant temperature amplification chip method)百康芯（天津）生物科技有限公司Tianjin BaiCarewww.bai-care.comNational Technology Plan2019 No.7
28传送鞘管Transmission sheath Medtronic,Inc.Medtronic,Inc.Medtronic,Inc.Clinical Urgent Use2019 No.6
27结核分枝杆菌复合群核酸检测试剂盒（恒温扩增-实时荧光法）Assay for mycobacterium tuberculosis complex group nucleic acid (constant temperature amplification - real-time fluorescence method)杭州优思达生物技术有限公司Hangzhou BiouStarwww.bioustar.comNational Technology Plan2019 No.6
26结核分枝杆菌特异性细胞免疫反应检测试剂盒（酶联免疫法）Assay for mycobacterium tuberculosis specific cellular immune response (enzyme-linked immunosorbent assay)广州市雷德生物科技有限公司Guangzhou Leide Biowww.leidebio.comNational Technology Plan2019 No.5
25百因止剂量指导软件Dosage guidance software for recombinant human coagulation factor VIIIBaxalta US Inc.Baxalta US Inc.www.shire.comClinical Urgent Use2019 No.5
24乙型肝炎病毒核酸测定试剂盒（RNA捕获探针法）Hepatitis B virus nucleic acid assay (RNA capture probe method)上海仁度生物科技有限公司Shanghai Rdbiowww.rdbio.comNational Technology Plan2019 No.4
23遗传性耳聋基因检测试剂盒（联合探针锚定聚合测序法）Hereditary deafness gene assay (combined probe anchor polymerization sequencing method)华大生物科技（武汉）有限公司Wuhan BGIwww.genomics.cnRare Diseases2019 No.3
22PD-L1检测试剂盒（免疫组织化学法）PD-L1 AssayDako North America, IncDako North America, Incwww.agilent.comClinical Urgent Use2019 No.2
21放射治疗轮廓勾画软件Software fortraiation therapy contour delineation深圳市旭东数字医学影像技术有限公司Shenzhen Yorktalwww.yorktal.comNational Technology Plan2019 No.1
20抗PD-L1 (SP142）兔单克隆抗体试剂（免疫组织化学法）Anti PD-L (SP142) Rabbit Monoclonal Antibody AssayRoche Diagnostics GmbHRoche Diagnostics GmbHwww.roche.comMaglinant Tumor2018 No.8
19镍钛合金紫杉醇洗脱血管支架Nickel-titanium alloy Paclitaxel-eluting vascular stentsBoston Scientific CorporationBoston Scientific Corporationwww.bostonscientific.comClinical Urgent Use2018 No.8
18活性生物骨烟台正海生物科技股份有限公司Yantai Zhbiowww.zhbio.comNational Technology Plan2018 No.7
17甲型/乙型流感及呼吸道合胞病毒核酸联合检测试剂盒（实时荧光PCR法）Influenza A and influenza B Virus RNA Assay (PCR-Fluorescence Probing)CepheidCepheidwww.cepheid.comClinical Urgent Use2018 No.6
16PD-L1检测试剂盒（免疫组织化学法）PD-L1 AssayDako North America,IncDako North America,Incwww.agilent.comClinical Urgent Use2018 No.5
15丝素蛋白无菌护创膜Silk fibroin sterile protective film浙江星月生物科技股份有限公司Zhejiang Xingyue biowww.xingyuebio.comNational Technology Plan2018 No.4
14肺动脉支架Pulmonary artery stent北京迈迪顶峰医疗科技有限公司Beijing Med Zenithwww.med-zenith.comClinical Urgent Use2018 No.3
13水通道蛋白4抗体测定试剂盒（酶联免疫法）AQP4Ab AssayRSR LimitedRSR Limitedwww.rsrltd.comRare Diseases2018 No.3
12药物洗脱外周血管支架Drug eluting peripheral stentsCOOk Ireland LimitedCOOk Ireland Limitedwww.cookmedical.euClinical Urgent Use2018 No.2
11结核分枝杆菌复合群核酸检测试剂盒（恒温扩增荧光法）Assay for mycobacterium tuberculosis complex group nucleic acid (constant temperature amplification fluorescence method)广州迪澳生物科技有限公司Guangzhou Deaouwww.deaou.cnNational Technology Plan2018 No.1
10结核分枝杆菌特异性细胞因子检测试剂盒（酶联免疫法）Assay for mycobecterium tuberculosis-specific cytokine (enzyme-linked immunosorbent assay)广州迪澳医疗科技有限公司Guangzhou Deaouwww.deaou.cnNational Technology Plan2018 No.1
9风疹病毒IgG抗体检测试剂（荧光免疫层析法）Rubella virus IgG antibody detection reagent (fluorescence immunochromatography)广州万孚生物技术股份有限公司Guangzhou Wongfowww.wondfo.com.cnNational Technology Plan2017 No.5
8麻疹病毒IgG抗体检测试剂（荧光免疫层析法）Measles virus IgG antibody assay (fluorescence immunochromatography)广州万孚生物技术股份有限公司Guangzhou Wongfowww.wondfo.com.cnNational Technology Plan2017 No.5
7硬性电凝切割内窥镜Rigid electrocoagulation cutting endoscope武汉唐济科技有限公司Wuhan Tangjiwww.whtangji.comNational Technology Plan2017 No.5
6疝修补片Hernia repair patch北京博辉瑞进生物科技有限公司Beijing BioSis Healingwww.biosishealing.comNational Technology Plan2017 No.4
5胸主动脉覆膜支架系统Thoracic aortic stent graft system北京华脉泰科医疗器械有限公司Beijing Huamai Taikewww.huamaitaike.comNational Technology Plan2017 No.4
4基因测序仪Genetic sequencer武汉华大智造科技有限公司Wuhan Mditechwww.mgitech.cnNational Technology Plan2017 No.4
3药物洗脱球囊导管Drug eluting balloon catheter辽宁垠艺生物科技股份有限公司Liaoning Yinyiwww.dlyinyi.comClinical Urgent Use2017 No.3
2中空纤维膜血液透析滤过器Hollow fiber membrane hemodiafiltration filter成都欧赛医疗器械有限公司Chengdu CdOciwww.cdoci.com.cnNational Technology Plan2017 No.2
1血液透析/滤过装置Hemodialysis/filtration device广州市暨华医疗器械有限公司Guangzhou Jihuawww.ji-hua.comNational Technology Plan2017 No.1
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