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Kappa Light Chain (κ-LC) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 151H50TSCRef 151H250TSC
Identity
- Trade Name
- Kappa Light Chain (κ-LC) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Kappa Light Chain (κ-LC) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 151H50TSC EUDAMED151H250TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-151H50TSC3W EUDAMEDD-151H250TSCL9 EUDAMED
- Basic UDI-DI
- B-151H50TSC3W EUDAMEDB-151H250TSCL9 EUDAMED
- EMDN Code
- W0102010109 KAPPA AND LAMBDA CHAIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Kappa Light Chain (κ-LC) Assay Kit (Immunoturbidimetric Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-151H50TSC3W | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 5f1dd2af-71ca-432b-996e-fd71c599f49b 61 fields · synced Oct 6, 2026
- EUDAMED abede43a-99ce-4eed-9119-d7c320f6edae 61 fields · synced May 18, 2026