Singclean

Primary DI

06936020140904

Basic UDI-DI Code

B-06936020140904

Reference

DOA-03-5t

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Singclean Medical Products Co., Ltd.

The Saliva Drug Rapid Test (Colloidal Gold Method) is a lateral flow chromatographic immunoassay for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates, Benzodiazepines, Barbiturates , Buprenorphine, Ketamine, ethadone, Methylenedioxymethamphetamine, Oxycodone, Phencyclidine, Propoxyphen, K2, Alcohol and their metabolites in saliva at the cut-off concentrations. The detection window when drugs can be detected in saliva specimens using this test is also indicated. This assay provides only a qualitative, preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid Chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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