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Approval for Innovative Medical Device’s Special Review and Priority Review in the First Half of 2019
2019-07-22 16:29

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 TimeAcceptance No.Product NameApplicant
12019/2/28CSZ1900042Hereditary deafness gene detection kit (combinatorial probe-anchor synthesis sequencing)Huada Biotechnology (Wuhan) Co., Ltd.
22019/4/10CSZ1900102Hepatitis B virus nucleic acid assay kit (RNA probe capture method)Shanghai Rendu Biotechnology Co., Ltd.
32019/5/27CSZ1900160Mycobacterium tuberculosis nucleic acid detection kit (isothermal amplification - real-time fluorescence method)Ustar Biotechnology Ltd.
42019/6/13CSZ1900198Respiratory pathogen nucleic acid detection kit (isothermal amplification chip method)Tianjin Baicare Biotechnology Co., Ltd
52019/6/24CSZ1900206Hepatitis B virus pgRNA (HBV-pgRNA) assay kit (PCR-fluorescence probe method)Hotgen Biotech Co., Ltd
62019/6/28CSZ1900199Newborn screening for non-derivative multiple genetic metabolic diseases (mass spectrometry)Suzhou Sym-Bio Life Science Co., Ltd.


No.Acceptance No.Product NameApplicant
1JSZ1800126PD-L1 detection kit (immunohistochemical method)Dako North America, Inc.


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