Eu Ivdd Eu Ivd Self Testing On The Market 🇨🇳 China

One-Step Drug Of Abuse Test 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP)

W.H.P.M. Bioresearch & Technology Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

Basic Information

Primary DI
D-6909620WHDUSEDDPZKEF
Basic UDI-DI Code
B-6909620WHDUSEDDPZKEF
Reference
WH-DU-S0x0801; WH-DU-S0x0802; WH-DU-S0x0803; WH-DU-S0x0804
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd Self Testing
Status
On The Market

Additional Description

TheOne-Step Drug of Abuse Test EDDP is a rapid chromatographic immunoassay for the qualitative detection of 2-Ethylidene-1,5-dimethyl-3,3 -dipheylpyrrolidine (EDDP) in human urine at a cut-off concentration of 300 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, Dip card and Multi-drug screen test Cup. All formats are packed and sealed in aluminum foil bags to ensure its validity before its expiration.

CND Nomenclature Codes

Code Description
W0102160507 METHADONE INCL. EDDP - RT & POC

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) HL 2101523-1

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