Zika Virus (ZIKV) Real Time RT-PCR Kit

Primary DI

06971042227585

Basic UDI-DI Code

B-06971042227585

Reference

ER-0360-02

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

SHANGHAI ZJ BIO-TECH CO., LTD

The Liferiver Zika Virus (ZIKV) Real Time RT-PCR 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). It is intended for the qualitative detection of Zika virus RNA. Serum, saliva and urine specimens are validated for use. The function of the assay is for the diagnosis or aid for diagnosis. Reactive results should be confirmed by details of confirmatory step which have been introduced in the Interpretation of Results. The assay is used to detect, define or differentiate a condition or risk factor of interest. The assay is manually operated and to be used with the RNA extraction kits and PCR instruments listed below. The assay is for use by a laboratory professional trained to use real time PCR in a laboratory setting. The use of RT-PCR method shortens the testing window, which is conducive to earlier identification and treatment of infection.

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