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Apolipoprotein Calibrator 2 (apo Cal 2)
EUDAMEDFDA UDIClass B (EU MDR)
Ref LP5047
Identity
- Trade Name
- APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) EUDAMEDFDA UDI
- Generic Name
- Multiple apolipoprotein IVD, calibrator FDA UDI
- Device Name
- APOLIPOPROTEIN CALIBRATOR EUDAMED
- Model / Reference
- LP5047 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273209204 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BAPOCAL01594 EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Multiple apolipoprotein 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
Apolipoprotein Calibrator 2 (apo Cal 2) 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 | 50552732BAPOCAL01594 | 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 20a11a83-ad89-4be2-ab9a-a1f18f4ddc2f 61 fields · synced Jun 18, 2026
- FDA UDI 665bf63e-b123-4c7e-9ec4-38ea8ff952b3 32 fields · synced May 29, 2026