VIROLOGY - RT & POC - OTHER

Primary DI

06970664750396

Basic UDI-DI Code

B-06970664750396

Reference

48Tests/kit

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

The kit is used for the qualitative detection Novel coronavirus (SARS-CoV-2) ORF1ab and E genes of pneumonia suspected cases of SARS-CoV-2 infection in Oropharyngeal swab and Saliva sample in vitro. The assay is used for the auxiliary diagnosis of the relevant cases and the emergency reserve of the epidemic in vitro during the period of pneumonia infected by SARS-CoV-2. The SARS-CoV-2 pneumonia diagnosis and SARS-CoV-2 infection control plan should be followed. This product can be operated in a non-laboratory protective environment and can realize POCT rapid detection

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