GENEDIAN

Primary DI

D-RA010UC

Basic UDI-DI Code

B-RA010UC

Reference

P122-05024

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou DIAN Biotechnology Co., Ltd.

The kit is used for in vitro qualitative detection of suspected cases of new coronavirus pneumonia, clustered cases and other cases that need to be diagnosed for new coronavirus infection. The kit is used to detect the ORF1ab and N genes of the novel coronavirus (SARS-CoV-2) in throat swabs and nasal swab samples. The test results of this kit are for clinical reference only and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.

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