SARS-CoV-2 Antigen Test Cassette

Primary DI

06970895472487

Basic UDI-DI Code

B-06970895472487

Reference

R220T01SB0C0

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Mole Bioscience Co., LTD.

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 andsaliva specimensfrom human.The test is intended to aid in the rapid differential diagnosis of SARSCoV-2 viral infection. Our SARS-CoV-2 Antigen Test Cassette was developed to detect the nucleocapsid protein (N-protein) of the virus, which is a conservative structural protein found in all SARS-CoV-2 mutant strains. The minimum age of users is 18 years.

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