Identity
- Trade Name
- SERUM INDICES (SERUM INDICES) EUDAMEDFDA UDI
- Generic Name
- Chromogen indicator IVD, kit, spectrophotometry FDA UDI
- Device Name
- SERUM INDICES EUDAMEDIntended for in vitro diagnostic (IVD) use to monitor the instrument’s response in detecting haemolyzed, icteric and lipemic samples. FDA UDI
- Model / Reference
- SI10448 EUDAMEDFDA UDI
- Description
- Intended for in vitro diagnostic (IVD) use to monitor the instrument’s response in detecting haemolyzed, icteric and lipemic samples. FDA UDI
Identifiers
- Catalog Number
- SI10448 FDA UDI
- Primary DI / UDI-DI
- 05055273217025 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BSEMDCE128EF EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
- GMDN Term
- Chromogen indicator IVD, kit, spectrophotometry 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
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
Serum Indices (serum Indices) 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 | 50552732BSEMDCE128EF | 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 c3a1816b-311d-4aff-8348-c073c6fa4ebc 61 fields · synced Jun 18, 2026
- FDA UDI d124a6f4-ebdf-44f3-9ad4-babb0839ea03 36 fields · synced May 29, 2026