VIROLOGY - NA REAGENTS - OTHER

Primary DI

08800204300607

Basic UDI-DI Code

B-08800204300607

Reference

RV007

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

KH Medical Co., Ltd.

The RADI CDZ Virus Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to detect the CDZ (Chikungunya, Dengue, and Zika) Virus RNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the mosquito borne CDZ viruses in human serum specimens obtained from patients with signs and symptoms of CDZ. 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).