← Back to catalogue
Serum Amyloid A Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass B (EU MDR)
Ref P15003Model 25 tests/box
Identity
- Trade Name
- Serum Amyloid A Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Serum Amyloid A Determination Kit (SAA Determination Kit) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP15003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975182500201 EUDAMED
- Basic UDI-DI
- 697518250P150036C EUDAMED
- Direct Marketing DI
- 06975182500201 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Serum Amyloid A Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P150036C | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a3e2615c-9f72-4837-b363-c3e1e6e81318 61 fields · synced Jun 19, 2026