Identity
- Trade Name
- RANSOD DILUENT (RANSOD DIL) EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- RANSOD DILUENT (RANSOD DIL) EUDAMEDThis is required for the dilution of heparinized or EDTA whole blood samples for use with the Randox Ransod Reagent. FDA UDI
- Model / Reference
- SD124 EUDAMEDFDA UDI
- Description
- This is required for the dilution of heparinized or EDTA whole blood samples for use with the Randox Ransod Reagent. FDA UDI
Identifiers
- Catalog Number
- SD124 FDA UDI
- Primary DI / UDI-DI
- 05055273206142 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732ARANDIL045EE EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 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
No
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
Ransod Diluent (ransod Dil) by Randox Laboratories Limited — Class A — 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 | 50552732ARANDIL045EE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 772c18f1-e7fc-47eb-8223-24da372da61f 61 fields · synced Jul 18, 2026
- FDA UDI b6301847-490c-4504-b918-2a8438ac5b1b 36 fields · synced May 30, 2026