Wanfu Bio has changed the registration information of the novel coronavirus antigen detection kit

On March 13, 2022, Wanfu Bio announced that the company has recently received a "Medical Device Registration Change Document" issued by the NMPA

Product Change Description

Before change:

【expected usage】

This product is used for the detection of novel coronavirus N antigen in oropharyngeal swabs and nasopharyngeal swab samples of people suspected of novel coronavirus pneumonia

This product should be used by professionally trained personnel in an environment that ensures biosafety and meets the conditions of use

After the change:

【expected usage】

This product is used for in vitro qualitative detection of novel coronavirus N antigen in oropharyngeal swabs, nasopharyngeal swabs, and nasal swab samples, and the sampling method of nasal swab samples has been added

This product cannot be used alone for the diagnosis of new coronavirus infection, and the infection status should be judged in combination with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history

Test-positive subjects should follow local epidemic prevention and control policies for reporting and isolation, and seek corresponding medical help; test-negative subjects should strictly abide by local epidemic prevention and control requirements, and if necessary, further use other more sensitive detection methods for confirmation , if it is still negative, continuous monitoring should be carried out and medical help should be sought in time