One-Step Drug of Abuse Test -Methylenedioxymethamphetamine (MDMA)

Primary DI

D-6909620WHDUSMDMA3BD7

Basic UDI-DI Code

B-6909620WHDUSMDMA3BD7

Reference

WH-DU-S0x0301; WH-DU-S0x0302; WH-DU-S0x0303; WH-DU-S0x0304

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

W.H.P.M. Bioresearch & Technology Co., Ltd.

The One-Step Drug of Abuse Test MDMA is a rapid chromatographic immunoassay for the qua litative detection of Methylenedioxymethamphetamine (MDMA) in human urine at a cut-off concentration of 500 ng/mL. This assay provides only a qualitative, preliminary analytical test result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Currently our products are in the format of Strip, Cassette, Dipcard and Multi-drug screen test Cup. All formats are packed and sealed in aluminum foil bags to ensure its validity before its expiration.

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