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6188440CE01

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, Anji313300 Huzhou, Zhejiang
PEOPLE'S REPUBLIC OF CHINA
SRN ID.:CN-MF-000017965
INFECTIOUS DESEASES (W0105, Class C)
In vitro diagnostic devices which require knowledge regarding immunoassays (IVP 3007)
Device Name: COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) 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.
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