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One Step Lysergic Acid Diethylamide Test Strip (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref GBLSD-101a
Identity
- Trade Name
- One Step Lysergic Acid Diethylamide Test Strip (Urine) EUDAMED
- Device Name
- One Step Lysergic Acid Diethylamide Test Strip (Urine) EUDAMED
- Model / Reference
- GBLSD-101a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GBLSD-101a2R EUDAMED
- Basic UDI-DI
- B-GBLSD-101a2R EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Lysergic Acid Diethylamide Test Strip (Urine) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-GBLSD-101a2R | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 91379a73-f92e-49d5-8743-22d8a416a75b 61 fields · synced Jun 19, 2026