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Liquid Csf Control - Level 1 (csf Control 1)
EUDAMEDFDA UDIClass B (EU MDR)
Ref CF10138
Identity
- Trade Name
- LIQUID CSF CONTROL - LEVEL 1 (CSF CONTROL 1) EUDAMEDFDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- CSF CONTROL EUDAMED
- Model / Reference
- CF10138 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273214567 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BCSFCON038D6 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050208 CSF CONTROLS EUDAMED
- GMDN Term
- Multiple-type clinical chemistry analyte profile 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
Liquid Csf Control - Level 1 (csf 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 | 50552732BCSFCON038D6 | 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 6be306f0-b0dc-4350-9d73-b0c6a5d9fcc1 61 fields · synced May 30, 2026
- FDA UDI 7e8874c2-f1db-4937-beab-c0cdafdeaefe 32 fields · synced May 30, 2026