After the intensive NMPA review, 7 IVD products from 7 companies successfully passed the CMDE review in the first half of 2019 (January- Jun 2019). These companies are Huada Biotechnology (Wuhan) Co., Ltd., Shanghai Rendu Biotechnology Co., Ltd., Hangzhou Ustar Biotechnology Co., Ltd., Baicare (Tianjin) Biotechnology Co., Ltd., Beijing Hotgen Biotechnology Co., Ltd., Suzhou Sym-Bio Life Science Co., Ltd., and Dako North America, Inc.
The results of priority review and special review for innovative medical device as follow:
| No. | Issuing Time | Acceptance No. | Product Name | Applicant |
| 1 | 2019/2/28 | CSZ1900042 | Hereditary deafness gene detection kit (combinatorial probe-anchor synthesis sequencing) | Huada Biotechnology (Wuhan) Co., Ltd. |
| 2 | 2019/4/10 | CSZ1900102 | Hepatitis B virus nucleic acid assay kit (RNA probe capture method) | Shanghai Rendu Biotechnology Co., Ltd. |
| 3 | 2019/5/27 | CSZ1900160 | Mycobacterium tuberculosis nucleic acid detection kit (isothermal amplification - real-time fluorescence method) | Ustar Biotechnology Ltd. |
| 4 | 2019/6/13 | CSZ1900198 | Respiratory pathogen nucleic acid detection kit (isothermal amplification chip method) | Tianjin Baicare Biotechnology Co., Ltd |
| 5 | 2019/6/24 | CSZ1900206 | Hepatitis B virus pgRNA (HBV-pgRNA) assay kit (PCR-fluorescence probe method) | Hotgen Biotech Co., Ltd |
| 6 | 2019/6/28 | CSZ1900199 | Newborn screening for non-derivative multiple genetic metabolic diseases (mass spectrometry) | Suzhou Sym-Bio Life Science Co., Ltd. |
| No. | Acceptance No. | Product Name | Applicant |
| 1 | JSZ1800126 | PD-L1 detection kit (immunohistochemical method) | Dako North America, Inc. |
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