Identity
- Trade Name
- Streptavidin-PE EUDAMED
- Device Name
- Streptavidin-PE EUDAMED
- Model / Reference
- 628511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888234400677 EUDAMED
- Basic UDI-DI
- 88823411W01030403C004KKK EUDAMED
- Direct Marketing DI
- 10888234400677 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class A 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
Streptavidin-PE by Immucor GTI Diagnostics, Inc. — Class A — IVDR — 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823411W01030403C004KKK | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc
- EUDAMED SRN
- US-MF-000020921
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (1)
- EUDAMED aca0d0f0-1eb5-496b-99c0-bc63933d8af4 61 fields · synced Jul 11, 2026