VIROLOGY - NA REAGENTS - OTHER

Primary DI

06937044500057

Basic UDI-DI Code

B-06937044500057

Reference

1060091

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ningbo HEALTH Gene Technologies Co., LTD.

This product is designed for qualitative detection of 13 respiratory pathogens by testing nucleic acid extracted from pharyngeal swab and sputum samples. The product can detect most major non-bacteria respiratory pathogens including general influenza A virus, influenza A virus H1N1 (2009), the seasonal influenza A virus H3N2, influenza B virus, human adenovirus, human Boca virus, human rhinovirus, human parainfluenza virus, human metapneumovirus, human coronavirus, human respiratory syncytial virus, Chlamydia, and Mycoplasma pneumonia. The laboratory personnel must be fully trained, or even certified if necessary, for professional operation of gene amplification analysis and should be skillful with the workflow for using this product. The laboratory should be equipped with biosafty amenities and implemented with safety procedures.

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