SARS-CoV-2 Nucleic Acid Detection Kit（qRT-PCR）

Primary DI

06974858690161

Basic UDI-DI Code

B-06974858690161

Reference

F6035

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Geneseeq Medical Device and Diagnostic Inc.

This kit is used for in vitro detection of viral RNA of novel coronavirus (SRAS-COV-2) ORF1ab and E genes in the oropharyngeal swab, nasopharyngeal swab and sputum from individuals who are suspected of COVID-19 by their healthcare provider, who are among cluster of COVID-19 cases, or who have other diagnostic needs determined by their healthcare provider. Test results of this kit are for clinical reference only, and should not be used as the sole criteria for clinical diagnosis and patient management decision. It is recommended to conduct a comprehensive examination on the patient condition in combination with clinical observations, patient history and epidemiological information. This kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques required for performing the test and in vitro diagnostic procedures.

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