SARS-CoV-2 Antigen Rapid Tests for Self-Testing

Primary DI

06952804807276

Basic UDI-DI Code

B-06952804807276

Reference

COV-S23004H/COV-S23006H

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

The SARS-CoV-2 Antigen Rapid Tests is a rapid visual immunoassay for the direct and qualitative detection of viral SARS-CoV-2 nucleoprotein antigens in nasal swabs. This test is intended for personal use by people aged 18 and over who are suspected to be infected with COVID-19. The SARS-CoV-2 Antigen Rapid Tests 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. Do not use this test on children under 2 years of age. The test procedure is not automated. Test results should not be used as a sole basis for diagnosis but should always be interpreted by a physician in the clinical context.

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