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Optilite Freelite Kappa Free Kit
EUDAMEDFDA 510(k)Class C (EU MDR)
Ref LK016.OPT510(k) K150658
Identity
- Trade Name
- Optilite Freelite Kappa Free Kit EUDAMED
- Device Name
- Optilite® Freelite® Kappa Free kit EUDAMED
- Model / Reference
- LK016.OPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051700017213 EUDAMED
- Basic UDI-DI
- 5051700LK016.OPT4H EUDAMED
- EMDN Code
- W0102010109 KAPPA AND LAMBDA CHAIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Optilite Freelite Kappa Free Kit by The Binding Site Group Ltd — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150658 | Class C | Active |
| FDA 510(k) | United States | FDA_510K | K010441 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 5051700LK016.OPT4H | Class C | Active |
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Manufacturer
- Manufacturer
- The Binding Site Group Ltd
- EUDAMED SRN
- UK-MF-000036707
- FDA Applicant
- The Binding Site Group , Ltd.
- Authorised Representative
- The Binding Site Ireland Limited IE-AR-000034426
Sources (2)
- EUDAMED 7fa3c642-80d5-4d6f-b823-154e4d1faea6 85 fields · synced Jun 18, 2026
- FDA 510(k) K150658 1 fields · synced Jun 9, 2026