COVID-19 & Influenza A/B Antigen Nasal Test Kit

Primary DI

06952804808976

Basic UDI-DI Code

B-06952804808976

Reference

MI-S33001H

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

The COVID-19 & Influenza A/B Antigen Nasal Test Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of viral nucleocapsid proteins of SARS-CoV-2, Influenza A virus, and Influenza B virus from nasal secretions. The test is for self-testing use. Children aged between 2 and 18 years old, must be supervised or aided by an adult when carrying out the test. Negative results do not preclude these viral infections. Testing results should not be the sole basis for treatment or other management decisions. This test is intended for asymptomatic and people who with symptoms of COVID-19 within the first 7 days of symptom onset. In individuals without COVID-19 symptoms and/or individuals who live in areas with low numbers of COVID-19 infections and without known exposure to COVID-19, more false positive results may occur. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test. Testing results should never be seen separated but always in the

Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).