6188440TD01
| EU Technical Documentation Assessment Certificate Conformity Assessment Regulation 2017/746 on In Vitro Diagnostic devices, Annex IX Chapter II and III | |
| Manufacturer: | Zhejiang Orient Gene Biotech Co., Ltd. 3787#, East Yangguang Avenue, Dipu Street, Anji 313300 Huzhou, Zhejiang PEOPLE'S REPUBLIC OF CHINA SRN ID.: CN-MF-000017965 |
| Class C, Self-testing | |
| Basic UDI-DI: 69509960GCFCRA-T525aDRH6M Device Name: COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) Type: W0105 INFECTIOUS DESEASES Model: GCFCRA-T525a-DRH1, GCFCRA-T525a-DRH5, GCFCRA-T525a-DRH7, GCFCRA-T525a-DRH20 | Intended Purpose: The COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative and differential detection of SARS-CoV-2, influenza A, influenza B, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) antigens in nasal swab specimens directly from individuals within the first seven days of symptom onset. It is intended to aid in the rapid diagnosis of SARS-CoV-2, influenza A, influenza B, RSV and Adenovirus infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) must be confirmed with alternative testing method(s) and clinical findings. It is for in vitro diagnosis use only. It is not automated. It is intended for Self-testing use and not for near patient use. Testing population: 1)Target population: People suspected with SARS-CoV-2, influenza A, influenza B, RSV and Adenovirus infections, including viral respiratory disease and include fever or chills, cough, shortness of breath or difficulty of breathing, fatigue, muscle or body aches, headache, the new loss of taste or smell, sore throat, congested or runny nose, nausea or vomiting or diarrhea, etc. 2) Intended user: Adults: over the age of 18 years can do a self-test and report. Adolescents: 12-17 years old can do a test under the supervision of an adult. Children: 3-11 years old should be tested by an adult. Do not conduct the test if you do not feel confident testing a child. Do not continue the test if the children feel pain. |
| Stutas | Valid |