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Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems
EUDAMEDFDA UDIClass C (EU MDR)
Ref NQ018.CBModel LK018.CB
Identity
- Trade Name
- Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems EUDAMEDFDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
- Device Name
- Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems EUDAMED
- Model / Reference
- LK018.CB EUDAMEDNQ018.CB EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700018845 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051700LK018.CBXT EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102010109 KAPPA AND LAMBDA CHAIN EUDAMED
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems by The Binding Site Group Ltd — Class C — IVDR, FDA UDI — listed in EUDAMED…
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 | 5051700LK018.CBXT | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group Ltd
- EUDAMED SRN
- UK-MF-000036707
- Authorised Representative
- The Binding Site Ireland Limited IE-AR-000034426
Sources (2)
- EUDAMED e3d2ed80-9207-4c3d-95e6-dab850867dc8 61 fields · synced Jun 6, 2026
- FDA UDI 34769b09-01e1-4699-811c-f9a76bfdca97 34 fields · synced May 30, 2026