One-Step Drug Of Abuse Test 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP)
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
- Manufacturer
- W.H.P.M. Bioresearch & Technology Co., Ltd.
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 | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2101523-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).