SARS-CoV-2 Antigen Test Cassette

Primary DI

06970895474139

Basic UDI-DI Code

B-06970895474139

Reference

R220T01PB0C0

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Jiangsu Mole Bioscience Co., LTD.

Device is for self-testing use. The SARS-CoV-2 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens in nasal swab samples from human. The test is intended to an aid in the rapid diagnosis of SARS-CoV-2 infection. The test utilizes the lateral flow immunoassay technology for the detection of nucleocapsid protein antigen in individuals with symptoms or suspected symptoms of SARS-CoV-2 infection.The self-testing cassette is suitable for people aged 15-70. People aged 15 to 70 who cannot test themselves can use it with help of other adults. The test provides preliminary test results. Negative results cannot exclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision. Also, the user should not take any decision of medical relevance without first consulting his or her medical practitioner.

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