Rapid Fentanyl Test Strip

Primary DI

06921963710710

Basic UDI-DI Code

B-06921963710710

Reference

1L35S3

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Xiamen Boson Biotech Co., Ltd.

Rapid Fentanyl Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of fentanyl in human urine specimens at cut-off level of 10 ng/ml. This assay has not been evaluated in the point of care location and is for use by Healthcare Professionals only. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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