Since January 2020, following the principle of "unified command, early involvement, prompt review and approval based on science", the Center for Medical Device Evaluation has fulfilled its duty to review medical products that meet the requirements of "safety, effectiveness and quality control".
By April 2, 25 2019-nCoV test kit registrations have been reviewed and fast issued by National Medical Product Administration (NMPA), through the emergency review and approval procedures. The intended use and basic information of these products are available:
1. Nucleic acid test kits for 2019-nCoV
1.1 Test kits detecting of 2019-nCoV
Specific genes
Intended use:
In vitro qualitative detection of target genes of 2019-nCoV from specimen of pneumonia patients suspected of 2019-nCoV infection, patients suspected of clustered cases, and other individuals requiring test for diagnosis or differential diagnosis with 2019-nCoV infections.
Product list:
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturing Site:Building #26, 588 Xinjunhuan Road, Minhang District, 201114 Shanghai, China
Applicable Specimen:Oropharyngeal swabs, Sputum, Bronchoalveolar Lavage Fluid (BALF)
Target Gene: ORF1ab gene, N gene and E gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Shanghai GeneoDx Biotechnology Co., Ltd.
Manufacturing Site:1st Floor, Building 3, Juke Bio-Park, 466 Yindu Road, Room 201, 203, 2nd Floor, Building 1, Juke Bio-Park, 466 Yindu Road, Room 104, 106, 108, Building 1, 2715 Longwu Road, Xuhui District, 200237 Shanghai, China
Applicable Specimen:Nasophayngeal swabs, Sputum
Target Gene: ORF1ab gene and N gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: BGI Biotechnology (Wuhan) Co., Ltd.
Manufacturing Site:5th floor Building B2, 1st floor Building B1, Zone B/C/D, Wuhan National Bioindustry Base, NO.666 Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan, Hubei, China
Applicable Specimen:Oropharyngeal swabs, Bronchoalveolar Lavage Fluid (BALF)
Target Gene: ORF1ab gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Da An Gene Co., Ltd. of Sun Yat-sen University
Manufacturing Site: No.19, Xiangshan Road, Science Park, High&New Technology Development District, Guangzhou; No.6, Lizhishan Road, Science Park, High&New Technology Development District, Guangzhou, China
Applicable Specimen:Oropharyngeal swabs, Sputum
Target Gene: ORF1ab gene and N gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Sansure Biotech Inc.
Manufacturing Site:No. 680, Lusong Road, 410205 Changsha, Hunan, China
Applicable Specimen:Oropharyngeal swabs, Bronchoalveolar Lavage Fluid (BALF)
Target Gene: ORF1ab gene and N gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Shanghai BioGerm Medical Biotechnology Co., Ltd.
Manufacturing Site:Room 1302, 1303, 1304, 1305, 1306, 1307, 1309, Building 3, No. 1588 Huhang Highway, Fengxian District, Shanghai, China
Applicable Specimen:Oropharyngeal swabs, Nasophayngeal swabs, Sputum
Target Gene: ORF1ab gene and N gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Beijing Applied Biological Technologies Co., Ltd.
Manufacturing Site:Room A204, 3rd floor B304, 2nd floor D203, D203-1, No.29 Shengmingyuan Road, Science Park, Changping District, 102206 Beijing, China
Applicable Specimen:Oropharyngeal swabs, Sputum
Target Gene: ORF1ab gene, N gene and E gene
Product Name: Nucleic Acid reagent test kit for novel coronavirus 2019-nCoV (fluorometric PCR)
Manufacturer Name: Maccura Biotechnology Co., Ltd.
Manufacturing ...










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