VIROLOGY - NA REAGENTS - OTHER

Primary DI

06928103014301

Basic UDI-DI Code

B-06928103014301

Reference

DA1430

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Daan Gene Co., Ltd.

The product is intended for the qualitative detection of nucleic acid from monkeypox virus. The kit uses real-time fluorescent PCR technology for the detection of the monkeypox virus DNA in patients’ rashes, scabs, vesicle fluid, pustule fluid, and whole blood specimens. It is a rapid, sensitive and accurate method, providing an accurate theoretical basis for clinical treatment. Test results of this kit are for clinical reference only, and cannot be used as the sole basis for confirming or excluding cases.

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