ZIKA VIRUS - NA REAGENTS

Primary DI

06928103007105

Basic UDI-DI Code

B-06928103007105

Reference

DA0710

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 qualitative detection of the specific fragment of NS1 gene of Asian and African lineage Zika viruses in serum, plasma, saliva, and urine specimens from individuals with an epidemiological history and symptoms including fever, rash, arthralgia, or conjunctivitis that are difficult to explain by other reasons. During clinical use, relevant laboratory testing requirements shall be complied. The test results of this kit are for clinical reference only, and cannot be used as the sole basis for confirming or excluding cases, and cannot be used for normal population screening.

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