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NGAL rapid test cassette (Rare earth nano fluorescence immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref IF032
Identity
- Device Name
- NGAL rapid test cassette (Rare earth nano fluorescence immunochromatography) EUDAMED
- Model / Reference
- IF032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323013549 EUDAMED
- Basic UDI-DI
- B-06974323013549 EUDAMED
- EMDN Code
- W0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NGAL rapid test cassette (Rare earth nano fluorescence immunochromatography) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD…
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-06974323013549 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 37970a1b-560c-49b5-81f4-6e99dae3839e 61 fields · synced Jul 10, 2026