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Urine/CSF Albumin Calibrator
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref B38859
Identity
- Trade Name
- Urine/CSF Albumin Calibrator EUDAMEDAU FDA UDI
- Generic Name
- Microalbumin IVD, calibrator FDA UDI
- Device Name
- Urine/CSF Albumin Calibrator EUDAMEDUrine CSF Albumin Calibrator FDA UDI
- Model / Reference
- B38859 EUDAMEDFDA UDI
- Description
- Urine CSF Albumin Calibrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590080983 EUDAMED15099590666361 FDA UDI
- Basic UDI-DI
- 150995902B38859T4 EUDAMED
- 510(k) Number
- K142346 FDA UDI
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Microalbumin IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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
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 Calibrator by Beckman Coulter Ireland Inc. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142346 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 150995902B38859T4 | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (3)
- EUDAMED f5ab24cb-4a95-4da0-82fe-0f75e9dc90d9 61 fields · synced Oct 7, 2026
- FDA UDI dfe1ab62-f152-4606-bcd9-508c43460fe6 34 fields · synced May 30, 2026
- FDA 510(k) K142346 1 fields · synced May 18, 2026