GENETIC TESTS - OTHER

Primary DI

06975977071503

Basic UDI-DI Code

B-06975977071503

Reference

600150

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Gold Probe Diagnostic Biotechnology Inc. MF

The kit is used for the qualitative detection New Coronavirus (SARS-CoV-2) ORF1ab, E and N 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).