One Step Multi-Drug Test Dip Card (Urine)

Primary DI

06950996098434

Basic UDI-DI Code

69509960GBDOA144008ZL

Reference

GBDOA-144-008

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

The One Step Multi-Drug Test Dip Card (Urine) is a rapid qualitative detection of multiple drugs of abuse and/or their metabolites in urine after drug consumption as an aid of diagnosis of drug abuse at the following cutoff concentrations: Amphetamine1000 ng/mL, Cocaine300 ng/mL, Morphine300 ng/mL, Marijuana50 ng/mL. The test provides only a preliminary result.It is intended for laboratory professional use at healthcare and drug rehabilitation setting. The One Step Multi-Drug Test Dip Card (Urine) are not intended for near-patient and not for self-testing. Intended testing population: People suspected with drug abuse, overdosed drug, drug dependence and abnormal psychiatric state.

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