Identity
- Trade Name
- Urine/CSF Albumin EUDAMEDAU FDA UDI
- Generic Name
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Urine/CSF Albumin EUDAMEDUrine CSF Albumin FDA UDI
- Model / Reference
- B46435 EUDAMEDFDA UDIB38858 EUDAMED
- Description
- Urine CSF Albumin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590020422 EUDAMEDFDA UDI15099590012076 EUDAMED
- Basic UDI-DI
- 150995902B46435RX EUDAMED150995902B38858T2 EUDAMED
- 510(k) Number
- K142346 FDA UDI
- FDA Product Code
- DCF FDA UDI
- EMDN Code
- W0102010309 ALBUMIN (IC) INCL. UALBUMIN EUDAMED
- GMDN Term
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5040 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Urine/CSF Albumin by Beckman Coulter Ireland Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995902B46435RX | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (3)
- EUDAMED 3f406840-012f-44a6-ad4a-e6542a392d3b 61 fields · synced Oct 6, 2026
- EUDAMED 53f298a6-387c-4bcc-9da0-d18ca751a709 61 fields · synced May 18, 2026
- FDA UDI fc3d78db-475d-4c44-961e-af0e7a8f4334 34 fields · synced May 30, 2026