Dengue Combo Rapid Test

Primary DI

06936983104876

Basic UDI-DI Code

6970277510000LXZ

Reference

IDEC-N425-10

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Hangzhou Alltest Biotech.Co.,Ltd.

The Dengue Combo Rapid Test is an in-vitro diagnostic rapid chromatographic immunoassay for the qualitative detection of NS1 antigen and IgG, IgM antibodies of Dengue virus in human whole blood, serum or plasma as an aid in the diagnosis of Dengue virus infections. The Dengue Combo Rapid Test is intended to be used by trained laboratory personnel. For laboratory use only. The test provides preliminary test results. Negative results will not preclude Dengue virus infection and they can’t be used as the sole basis for treatment or other management decision. The test is not automated. Not for self-testing use. Not for near-patient use.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).