Identity
- Trade Name
- LinkSēq HLA-B 384 Typing Kit EUDAMED
- Device Name
- LinkSēq™ HLA Typing Kits EUDAMED
- Model / Reference
- 2322C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814695025510 EUDAMED
- Basic UDI-DI
- 081469502LNQHM EUDAMED
- Direct Marketing DI
- 00814695025510 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
LinkSēq HLA-B 384 Typing Kit by One Lambda, Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
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- SSP HLA-A*80 — CareDx AB · IVD Annex II List B
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081469502LNQHM | Class C | Active |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
- EUDAMED SRN
- US-MF-000024901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 44e93e8f-ecbc-473e-a169-1b29946253ac 61 fields · synced Jun 20, 2026