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Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 152H50TSCRef 152H250TSC
Identity
- Trade Name
- Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 152H50TSC EUDAMED152H250TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-152H50TSC4F EUDAMEDD-152H250TSCLU EUDAMED
- Basic UDI-DI
- B-152H50TSC4F EUDAMEDB-152H250TSCLU 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
Lambda Light Chain (λ-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-152H50TSC4F | 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 01f49a72-f44f-4c6b-be4d-f5c3a7fe48a6 61 fields · synced Oct 6, 2026
- EUDAMED f3839870-a20a-4121-b879-6c73c7f1d40a 61 fields · synced May 18, 2026