RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS

Primary DI

08800204300225

Basic UDI-DI Code

B-08800204300225

Reference

RV012F

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

KH Medical Co., Ltd.

The RADI FAST RSV A/B Detection Kit is an in vitro diagnostic medical device, based on Real-time RT-PCR technology utilizing reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA). The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the Respiratory Syncytial Virus (RSV) in Upper respiratory specimens such as Nasopharyngeal swab. This kit is intended for the differential detection of the RSV genotypes A and B. 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).