One Step Multi-Drug Test Dip Card (Urine)

Primary DI

06950996041393

Basic UDI-DI Code

69509960GBDOA1144002J8

Reference

GBDOA-1144-002

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:Amphetamine1000ng/mL,Barbiturates300ng/mL,Benzodiazepines300 ng/mL,Buprenorphine10ng/mL, Cocaine300 ng/mL,EDDP300ng/mL,Marijuana50ng/mL,Methamphetamine1000ng/mL,Me thadone300ng/mL,MDMA500ng/mL,Morphine300ng/mL,Oxycodone10 Ong/mL,Phencyclidine25ng/mL,TricyclicAntidepressants1000ng/mL.The Specific combination of multi-Drug will be determined according to the REF of One Step Multi-Drug Test Dip Card (Urine). 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).