Securities code: Guangzhou Wondfo Biotech Co.Ltd(300482) securities abbreviation: Guangzhou Wondfo Biotech Co.Ltd(300482) Announcement No.: 2022021 bond Code: 123064 bond abbreviation: Wanfu convertible bond
Guangzhou Wondfo Biotech Co.Ltd(300482)
Notice on changes of approval documents of New Coronavirus antigen detection kit
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Guangzhou Wondfo Biotech Co.Ltd(300482) (hereinafter referred to as “the company”) recently received a medical device registration change document issued by the State Drug Administration.
1、 Basic product information
Serial number name registration classification Registration Certificate No
1 detection of New Coronavirus (2019-nCoV) antigen class III
Kit (colloidal gold method) 20203400830
2、 Product change description
Before change:
[intended use]
This product is used for the detection of new coronavirus n antigen in oropharyngeal swab and nasopharyngeal swab samples of people suspected of pneumonia caused by new coronavirus. It is generally used for sample detection in the acute infection period, that is, within 7 days of symptoms in the suspected population.
This product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions. New Coronavirus antigen detection should comply with the requirements of COVID-19 virus sampling and testing technology guide.
After change:
[intended use]
This product is used to qualitatively detect the new coronavirus n antigen in oropharyngeal swab, nasopharyngeal swab and nasal swab samples in vitro, and increases the sampling method of nasal swab samples.
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 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.
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).
3、 Impact on the company and risk tips
The State Council should decide to promote the monitoring mode of “antigen screening and nucleic acid diagnosis” to the comprehensive group of New Coronavirus pneumonia epidemic prevention and control mechanism. On the basis of nucleic acid detection, it adds antigen detection as a supplement to the nasal swab sampling method of antigen detection reagent, and expands the application scenario, which is conducive to improving the ability of “early detection”. In strict accordance with the deployment of relevant central departments, adhering to the concept of “no waiting for life”, the company will provide strong and orderly support for the fight against the epidemic, and better protect every health with rapid detection technology.
The actual sales of the above products are affected by many factors, such as covid-19 epidemic change, prevention and control policy, detection demand, change of the company’s supply chain capacity, logistics and transportation risk and unpredictable or force majeure. The company is unable to predict the specific impact of the product on future performance. The company will timely perform the corresponding information disclosure business in strict accordance with relevant regulations. Please pay attention to investment risks.
It is hereby announced.
Guangzhou Wondfo Biotech Co.Ltd(300482) board of directors March 13, 2022
