MYCOPLASMA DETECTION BY NA REAGENTS

Primary DI

06973492240169

Basic UDI-DI Code

B-06973492240169

Reference

U20201

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ustar Biotechnologies (Hangzhou) Ltd.

This kit is an automated, in vitro nucleic acid amplification test used for the qualitative detection of the Mycoplasma pneumoniae (MP) in Oropharyngeal swabs samples collected from individuals with suspected signs and/or symptoms of MP infection. This kit can be used for auxiliary diagnosis of Mycoplasma pneumoniae infection, and provides molecular diagnostic basis for MP infection. This kit is not for near patient and self-testing.

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