Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) Professional Use

【Product name】

Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) [Professional use]

【Model】

HYT-G01-01 Nasopharyngeal swab

HYT-G01-02 Oropharyngeal swab

HYT-G01-03 Saliva

【Intended use】

The product is used for the qualitative detection of human nasopharyngeal swabs and oropharyngeal swabs and saliva of Corona Virus (COVID-19) Nucleocapsid Antigen. It is only used as a supplementary test for the nucleic acid test of novel coronavirus or in cooperation with nucleic acid test in suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by novel coronavirus infection, and is not suitable for general screening. For medical institution use only, and biosecurity protection should be done in laboratory when testing of novel coronavirus. The results of this kit are only for clinical reference. If the test result is positive, further confirmation is needed. If the test result is negative, the possibility of infection cannot be excluded. Comprehensive analysis of the patient's condition should be carried out in combination with clinical symptoms and other laboratory tests.

【Certification】

ISO 13485 

Certificate of CE Registration

Germany PEI Evaluation

EU HSC Common List