Securities code: Nanjing Vazyme Biotech Co.Ltd(688105) securities abbreviation: Nanjing Vazyme Biotech Co.Ltd(688105) Announcement No.: 2022007
Nanjing Vazyme Biotech Co.Ltd(688105)
On voluntary disclosure of wholly owned subsidiaries
Announcement on the change of medical device registration certificate
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or
And shall bear legal responsibility for the authenticity, accuracy and integrity of its contents in accordance with the law.
Nanjing Vazyme Biotech Co.Ltd(688105) (hereinafter referred to as “the company”) Nanjing Nuo, a wholly-owned subsidiary
Vizan Medical Technology Co., Ltd. (hereinafter referred to as ” Nanjing Vazyme Biotech Co.Ltd(688105) medical”) obtained from
Medical device registration change document (in vitro diagnostic reagent) approved by the State Drug Administration. Promise
The New Coronavirus antigen test kit for medical treatment is expected to complete the registration of medical device products.
In transit, add the change of sample type and instruction content, and the specific conditions are as follows:
1、 Basic information and change content of registration certificate
Product name registrant name registration certificate number main changes
New Coronavirus Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) national standard for original use [expected purpose]:
(2019- medical technology has 20223400346 products for New Coronavirus infected pneumonia suspect throat oropharyngeal swab, nCoV) antigen detection company’s nasopharyngeal swab samples New Coronavirus N antigen and S antigen detection. General test kit (glue is used in the acute infection period, i.e. the gold method of the sample within 7 days of the symptoms of the suspected population). This product can not be used alone for the diagnosis of New Coronavirus infection. It should be combined with nucleic acid detection, imaging and other diagnostic information and history, contact history to determine the infection status. The positive results can be used for early shunting and rapid management of suspected populations, but positive results only indicate that New Coronavirus N antigen and / or S antigen exist in the samples, which can not be used as a diagnostic basis for New Coronavirus infection. Negative results can not exclude New Coronavirus infection, nor should it be used alone as a basis for treatment and disease management decisions. Further nucleic acid testing should be carried out for antigen positive and negative results of suspected people. This product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions.
Changed [intended use]:
This product is used for the qualitative detection of New Coronavirus (2019-nCoV) N antigen and S antigen in oral throat swabs, nasopharyngeal swabs and nasal swabs samples in vitro. The applicable population shall refer to the application scheme for covid-19 virus antigen detection (Trial Implementation) and other relevant national regulations. This product can not be used alone for the diagnosis of New Coronavirus infection. It should be combined with nucleic acid detection, imaging and other diagnostic information and history, contact history to determine the infection status. The positive results can be used for early shunting and rapid management of suspected populations, but positive results only indicate that New Coronavirus antigen exists in the samples, which can not be used as a diagnostic basis for New Coronavirus infection. Negative results are not
Securities code: Nanjing Vazyme Biotech Co.Ltd(688105) securities abbreviation: Nanjing Vazyme Biotech Co.Ltd(688105) Announcement No.: 2022007
It can exclude New Coronavirus infection and should not be used alone as a basis for treatment and disease management decisions. Further nucleic acid testing should be carried out for antigen positive and negative results of suspected people. The test positive subjects should report and isolate according to the local epidemic prevention and control policy, and seek corresponding medical help; Test negative subjects should strictly comply with the local epidemic prevention and control requirements, and further take other more sensitive detection methods for confirmation if necessary. If they are still negative, they should continue to monitor and seek medical help in time. The product use environment shall comply with relevant national regulations such as covid-19 virus antigen detection application scheme (Trial).
Note: for other registration information changes, please refer to the product manual II. Impact on the company and risk tips
The above changes further respond to the national covid-19 epidemic prevention, control and detection policy and help to further enhance the company’s competitiveness in relevant fields. The actual sales situation of the above-mentioned New Coronavirus antigen detection products is affected by many factors such as COVID-19 epidemic situation, prevention and control policy and testing demand. The company can not predict the specific impact of the product’s sales on the future performance.
It is hereby announced.
Nanjing Vazyme Biotech Co.Ltd(688105)
Board of directors
March 14, 2022
