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Neutrophil Gelatinase Associated Lipocalin (NGAL) Assay Kit (Latex Immunoturbid…
EUDAMEDClass IVD General (EU MDR)
Ref R1:20mL×1 R2:5mL×1(702)Ref R1:64mL×2 R2:16mL×2(701117)
Identity
- Trade Name
- Neutrophil Gelatinase Associated Lipocalin (NGAL) Assay Kit (Latex Immunoturbidimetric) EUDAMEDNeutrophil Gelatinase Associated Lipocalin (NGAL) Assay Kit(Latex Immunoturbidimetric) EUDAMED
- Device Name
- Neutrophil Gelatinase Associated Lipocalin (NGAL) Assay Kit (Latex Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:20mL×1 R2:5mL×1(702) EUDAMEDR1:64mL×2 R2:16mL×2(701117) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869931 EUDAMED06971674869917 EUDAMED
- Basic UDI-DI
- B-06971674869931 EUDAMEDB-06971674869917 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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
Category: Nucleic acid extraction/isolation kit IVD
Neutrophil Gelatinase Associated Lipocalin (NGAL) Assay Kit (Latex Immunoturbid… by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed…
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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-06971674869931 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 7847362c-0215-4214-a332-2cec7f44d954 61 fields · synced Oct 6, 2026
- EUDAMED 244ecced-007e-49ef-994c-74f59ba2cabc 61 fields · synced May 17, 2026