Securities code: Shanghai Zj Bio-Tech Co.Ltd(688317) securities abbreviation: Shanghai Zj Bio-Tech Co.Ltd(688317) Announcement No.: 2022024 Shanghai Zj Bio-Tech Co.Ltd(688317)
Announcement on voluntary disclosure of relevant certification of the company's products
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of the announcement, and bear legal responsibility for the authenticity, accuracy and integrity of the contents according to law.
Shanghai Zj Bio-Tech Co.Ltd(688317) (hereinafter referred to as "the company") and its wholly-owned subsidiary Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) Pharmaceutical Technology Co., Ltd. have recently obtained six relevant certifications or registrations, one of which is the national class III medical device registration certificate and the other five are EU CE certification. The specific situation is hereby announced as follows:
1、 Details of medical device registration certificate
Product name certificate number registration certificate validity registration classification scope of application
Automatic nucleic acid extraction and purification and real-time fluorescence PCR analysis system for class III fully automatic samples 20223220432 of state machinery injection standard on April 2, 2022 to nucleic acid extraction and purification on April 1, 2027 and PCR detection and analysis
2、 EU CE certification
Product name certificate number application field validity
Liferiver intelligent molecular cibg-20221094 genome research, effective during molecular growth
Mobile Mini lab physics laboratory scientific research
Automatic nucleic acid extraction and purification and real-time and clinical gene detection
Fluorescence PCR analysis system
Specifications pretreatment system cibg-20221094 sample pretreatment is effective for a long time
(QGMate)
Sample pretreatment system
Automated workstation for cibg-20221094 genome research, effective in molecular growth period
Nuclear acid extraction and physical science laboratory
PCR test (austramic mini4800) and clinical gene detection
Plus)
Automatic nucleic acid extraction, purification and real-time
Fluorescent PCR analysis system
Automated workstation for cibg-20221094 genome research, effective in molecular growth period
Nucleicacid Extraction & scientific research in Physics Laboratory
PCR setup (austra4800 plus) and clinical gene detection
Automatic pre-processing system for nucleic acid detection
Liferiver sars-cov-2 484A TP 01912022 pathogen nucleic acid detection 202505-26
Mutation Detection Kit New Coronavirus (SARS-CoV-2)
484A mutation detection kit
3、 Product details
Product Name: intended use scope of the certified subject
Full automatic nucleic acid extraction and purification and Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) medicine, based on PCR technology, can extract and analyze nucleic acids from nmpa approved by clinical samples, including the country of the disease, geovirology, microbiology, etc
Quantity detection.
Liferiver intelligent Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) medical, based on PCR technology, can extract and analyze nucleic acids from clinical samples approved by EU CE Mini lab, including national automatic nucleic acid extraction and purification with disease certification, and qualitative and quantitative analysis of toxicology and microbiology
Real time fluorescence PCR analysis system was used for quantitative detection.
Specifications pretreatment Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) medical sample pretreatment EU countries and countries recognized by system (qgmate) Pharmaceutical Technology Co., Ltd. as EU CE sample pretreatment system certification
Automated workstation Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) Medical Technology Co., Ltd. can quickly, efficiently and accurately complete the nucleic acid extraction and PCR reaction system of EU countries and for nuclear acid Pharmaceutical Technology Co., Ltd. and the countries (austramic mini4800) recognized by the EU ceextraction and PCR test construction, PCR detection, result analysis and other certification.
Its automatic operation process can
Plus) effectively reduce the error of manual operation,
Automatic nucleic acid extraction and purification and improve the accuracy of the test.
Real time fluorescent PCR analysis system
Automated workstation Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) medical is used in clinical sample processing, nucleic acid extraction, nucleic acid detection preparation in EU countries and countries recognized by EU CE Extraction & PCR setup certification (austra4800 plus)
system
Liferiver SARS-CoV-2 Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) Department nasopharyngeal swabs and oropharyngeal swabs specimens from the EU countries and 484AMutation Detection technology Limited by Share Ltd SARS-CoV-2 484A mutation were approved by the EU CE Kit external qualitative testing and certification of national New Coronavirus (SARS-CoV-2) 484A.
Mutation detection kit
4、 Impact on the company
After obtaining relevant certification, the above products of the company can be sold in the corresponding recognized countries and regions, enriching the types of instruments and equipment products of the company, providing more professional, efficient and experienced automatic nucleic acid detection solutions for the application of global molecular diagnosis, including covid-19 epidemic prevention and control, further improving the international competitiveness of the company and playing a positive role in the international business expansion of the company. Among them, "qinggeng-1" high-throughput automatic nucleic acid detection platform (automatic nucleic acid extraction and purification and real-time fluorescent PCR analysis system) has completely independent intellectual property rights and a high-throughput and automatic nucleic acid detection platform integrating a variety of independent innovative technologies, which can support intelligent, multi-purpose and multi scene mobile detection mode. The introduction of this product can realize the fully automatic nucleic acid detection process of "sample in, result out", which plays a positive role in promoting the application and popularization of nucleic acid detection.
5、 Risk tips
1. Product competition risk
In addition to the relevant certification of the company's products, the relevant products of other companies are also supplied to the market, so the company's products may face the market competition risk of similar products or other testing products.
2. Uncertain risk on profit impact
Affected by the epidemic development and epidemic prevention and control policies, market competition, the path selection of international epidemic on technical products, the company's product competitiveness and channel ability, customer recognition and other factors, the sales and profit contribution of the above products are highly uncertain. The impact of the market revenue of the above products on the overall revenue of the company is uncertain. See the company's periodic report for the specific revenue of domestic and foreign markets.
3. Secondary market fluctuation risk
The company specially reminds investors to pay attention to the risk of stock price fluctuation in the secondary market, avoid following the trend of speculation, make rational decisions and invest prudently.
The company solemnly reminds investors that Shanghai Securities News, China Securities News, securities times and Securities Daily are the information disclosure newspapers designated by the company, and the website of Shanghai Stock Exchange (www.sse. Com. CN.) Specify an information disclosure website for the company. All information of the company shall be subject to the information published in the above designated media. Please pay attention to investment risks.
It is hereby announced.
Shanghai Zj Bio-Tech Co.Ltd(688317) board of directors April 8, 2022
