Logilet Respiratory Pathogen Panel

Primary DI

06973315734882

Basic UDI-DI Code

B-06973315734882

Reference

VD1011

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Nanjing Vazyme Medical Technology Co.,Ltd.

This product is intended for in vitro qualitative detection and discrimination of nucleic acids of respiratory syncytial virus, influenza A virus, influenza B virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), human adenovirus, and Mycoplasma pneumoniae in human nasopharyngeal swabs. The test results can be used as an aid in the diagnosis of respiratory syncytial virus, influenza A virus, influenza B virus, SARS-CoV-2, human adenovirus, and Mycoplasma pneumoniae infections. The kit is intended for use by operators in laboratory or point-of-care settings.

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