VIROLOGY - NA REAGENTS - OTHER

Primary DI

08800204300621

Basic UDI-DI Code

B-08800204300621

Reference

RV015

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

KH Medical Co., Ltd.

The RADI Monkeypox Detection KIT is an in vitro diagnostic medical device, based on Real-time PCR technology to detect the Monkeypox DNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the Monkeypox in human skin lesion, crust or swab specimens obtained from patients with signs and symptoms of Monkeypox. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.

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