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Csf Control - Level 3 (csf Control 3)
EUDAMEDFDA UDIClass B (EU MDR)
Ref CF1501
Identity
- Trade Name
- CSF CONTROL - LEVEL 3 (CSF CONTROL 3) EUDAMEDCSF CONTROL - LEVEL 3 (CSF CONTROL 3) FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- CSF CONTROL EUDAMEDThis product is intended for in vitro diagnostic use, in the quality control of diagnostic methods using CSF as a sample on clinical chemistry systems. The CSF controls are for the control of accuracy. FDA UDI
- Model / Reference
- CF1501 EUDAMEDFDA UDI
- Description
- This product is intended for in vitro diagnostic use, in the quality control of diagnostic methods using CSF as a sample on clinical chemistry systems. The CSF controls are for the control of accuracy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273201123 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
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
Csf Control - Level 3 (csf Control 3) 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 | 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 e17beb3c-2a60-4d94-a94e-cc6da3b817cf 61 fields · synced Jul 10, 2026
- FDA UDI 3f04f22b-9ecc-40b1-8dd0-40038cba0b5a 35 fields · synced May 30, 2026