MYCOLOGY NA REAGENTS - OTHER

Primary DI

06930317801943

Basic UDI-DI Code

B-06930317801943

Reference

DNK-2109-1

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Dynamiker Biotechnology (Tianjin) Co., Ltd.

The MycoMDx Pneumocystis jirovecii (PJP) PCR Assay is a multiplex polymerase chain reaction (PCR) in vitro diagnostic (IVD) test for the detection of Pneumocystis jirovecii DNA extracted from bronchoalveolar lavage fluid (BALF)obtained from human patients considered at risk of invasive fungal disease (IFD). This kit can detect pathogenic Pneumocystis. This method has high sensitivity and specificity, which is of great significance for the early diagnosis and treatment of invasive Pneumocystis jirovecii infections.

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