CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

Primary DI

06974858560556

Basic UDI-DI Code

B-06974858560556

Reference

P071H

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Suzhou TianLong Biotechnology Co., Ltd.

The test is designed to detect RNA from MERS-CoV in specimens such as nasopharyngeal or oropharyngeal swabs collected from individual personnel based on clinical and/or epidemiological criteria. Other sample types from the upper and lower respiratory tract (such as sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate), as well as samples collected from the environment, may serve the purpose for virus detection as well if adequate MERS-CoV RNA could be extracted from the samples. The potential candidate personnel to be tested could include, but are not limited to patients with symptoms of infection who are suspected of MERS-CoV by healthcare providers, or persons with no symptoms from a population for screening test confirmation or exclusion of viral infection or viral carriage status.

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