← Back to catalogue
LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)
EUDAMEDFDA UDIClass B (EU MDR)
Ref LP3406
Identity
- Trade Name
- LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) EUDAMEDFDA UDI
- Generic Name
- Lipoprotein A IVD, control FDA UDI
- Device Name
- LIPOPROTEIN (a) CONTROL EUDAMEDRandox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a). FDA UDI
- Model / Reference
- LP3406 EUDAMEDFDA UDI
- Description
- Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273204445 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BLIPCON082K4 EUDAMED
- FDA Product Code
- JIS FDA UDIDFC FDA UDIJJS FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Lipoprotein A IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI866.5600 FDA UDI862.1660 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) 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 | 50552732BLIPCON082K4 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 4b1f1e4b-be46-4b9b-a524-7be26211dc2b 61 fields · synced Jul 16, 2026
- FDA UDI 7c95a6b8-07b6-408b-aed9-1b406fccfe48 35 fields · synced May 30, 2026