Multi-Drug Test Cup XR (Colloidal Gold)

Primary DI

06974521003083

Basic UDI-DI Code

B-06974521003083

Reference

SUPG128025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

Multi-Drug Test Cup XR (Colloidal Gold) is an immuno-chromatographic assay for qualitative and simultaneous detection of the presence of drugs in human urine which are listed in the table below. See the table in IFU.Configuration of the Multi-Drug Test Cup XR (Colloidal Gold) can consist of any combination of the above listed drug analytes. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

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