Identity
- Trade Name
- Trousse NG-Mix Multiloci EUDAMED
- Device Name
- Trousse NG-Mix Multiloci pour le génotypage des allèles HLA en haute résolution par la méthode Nouvelle Génération de Séquençage (NGS) EUDAMED
- Model / Reference
- 265857 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760369290371 EUDAMED
- Basic UDI-DI
- B-03760369290371 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
Trousse NG-Mix Multiloci by Etablissement Francais Du Sang — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
- LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit — ONE LAMBDA, INC. · Class C
- LABType™ HD Class I B Locus Typing Test - 20 tests — ONE LAMBDA, INC. · U
- SSP DRB1*13 — CareDx AB · IVD Annex II List B
- SSP HLA-A*25 — CareDx AB · IVD Annex II List B
- HLA Class I Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody — ONE LAMBDA, INC. · U
- SSP HLA-B*67 — CareDx AB · IVD Annex II List B
- Micro SSP™ AmbiStrips™ HLA Class I - A0101N — ONE LAMBDA, INC. · U
- SSP HLA-B*41 — CareDx AB · IVD Annex II List B
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-03760369290371 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Etablissement Francais Du Sang
- EUDAMED SRN
- FR-MF-000013221
Sources (1)
- EUDAMED c348061f-5162-410c-bd4a-dcaed8c4fbdd 61 fields · synced Oct 6, 2026