2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Primary DI

06974521001744

Basic UDI-DI Code

B-06974521001744

Reference

SUPL010025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro qualitative detection of 2019-nCoV antigen. Positive result from the test need further analyze with clinical history of patient and other diagnostic information to determine patient infection status. Positive value is only a reference guide for clinical diagnosis. The test results only reflect the current state of the sample. Negative result cannot exclude 2019-nCoV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. This test is only for clinical laboratory, medical institutions use or for real-time inspection by professional medical staff, not for home testing. It cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by 2019-nCoV and is not suitable for general population screening. The laboratory testing of 2019-nCoV should meet the requirements of the "Laboratory testing for 2019-nCoV in suspected human cases" and other requirements, and pay attention to the biosecurity.

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