序号 | 产品名称 | 注册人名称 | 注册证编号 |
境内第三类医疗器械 |
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| 乙型肝炎病毒核心抗体测定试剂盒(化学发光免疫分析法) | | |
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| 新型冠状病毒2019-nCoV和甲型乙型流感病毒核酸检测试剂盒(荧光PCR法) | | |
| 单纯疱疹病毒1+2型IgG抗体(HSV1+2 IgG)检测试剂盒(光激化学发光法) | | |
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| 新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法) | | |
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| 吗啡/甲基安非他明/氯胺酮唾液联合检测试剂盒(胶体金法) | | |
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| 新型冠状病毒(2019-nCoV)核酸检测试剂盒(PCR-荧光探针法) | | |
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| 人类ApoE 、SLCO1B1基因多态性检测试剂盒(荧光PCR法) | | |
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| 甲型流感病毒IgM抗体检测试剂盒(磁微粒化学发光法) | | |
| 肺炎支原体IgG抗体检测试剂盒(量子点荧光免疫层析法) | | |
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| 新型冠状病毒(2019-nCoV)抗原检测试剂盒(乳胶法) | | |
| 新型冠状病毒(2019-nCoV)核酸检测试剂盒(荧光PCR法) | | |
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| 人类SLCO1B1和ApoE基因检测试剂盒(PCR-荧光探针法) | | |
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| 人乳头瘤病毒基因分型(18型)检测试剂盒(PCR-反向点杂交法) | | |
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进口第三类医疗器械 |
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| | Bard Access Systems, Inc. | |
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| | W. L. GORE & ASSOCIATES, INC. | |
| | Integra LifeSciences Corporation | |
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| | Johnson & Johnson Surgical Vision, Inc. | |
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| | inomed Medizintechnik GmbH | |
| | Boston Scientific Corporation | |
| | Spectranetics Corporation | |
| | Osstem Implant Co., Ltd. (奥齿泰种植体有限责任公司) | |
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| | Mallinckrodt Manufacturing LLC | |
| | Medtronic Sofamor Danek USA, Inc. | |
| | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | |
进口第二类医疗器械 |
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| | Siemens Healthcare Diagnostics Inc. | |
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| | Megadyne Medical Products Inc. | |
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| | Instrumentation Laboratory Company | |