Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Primary DI

06974521005278

Basic UDI-DI Code

B-06974521005278

Reference

SUPG15902518

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold) is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. For professional use only.（See IFU for the table）

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