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MICROALBUMIN CALIBRATOR SERIES (mALB CAL)
EUDAMEDFDA UDIClass B (EU MDR)
Ref MA1567
Identity
- Trade Name
- MICROALBUMIN CALIBRATOR SERIES (mALB CAL) EUDAMEDFDA UDI
- Generic Name
- Microalbumin IVD, calibrator FDA UDI
- Device Name
- MICROALBUMIN CALIBRATOR SERIES EUDAMED
- Model / Reference
- MA1567 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273204520 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BMALBCL08688 EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) 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
- Northern 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MICROALBUMIN CALIBRATOR SERIES (mALB CAL) by Randox Laboratories Limited — 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 | 50552732BMALBCL08688 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED c2d891df-709f-4838-9519-b5b19e42c701 61 fields · synced Jul 15, 2026
- FDA UDI 39eeace6-47d8-4f09-8880-dfae73210476 32 fields · synced May 30, 2026