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Apolipoprotein Control - Level 1 (apo Control 1)
EUDAMEDFDA UDIClass B (EU MDR)
Ref LE5016
Identity
- Trade Name
- APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) EUDAMEDAPOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) FDA UDI
- Generic Name
- Multiple apolipoprotein IVD, control FDA UDI
- Device Name
- APOLIPOPROTEIN CONTROL EUDAMED
- Model / Reference
- LE5016 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273209105 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BAPOCON016EE EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
- GMDN Term
- Multiple apolipoprotein IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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 Control - Level 1 (apo Control 1) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50552732BAPOCON016EE | 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 23f723be-7c2a-441f-97e5-8862cf6bb043 61 fields · synced Jul 18, 2026
- FDA UDI 6da7d167-ef86-436e-b4a3-7d58c799a541 32 fields · synced May 30, 2026