Identity
- Trade Name
- Dilution Solution EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Dilution Solution EUDAMEDFor Use with HLA-SSO Typing Kits FDA UDI
- Model / Reference
- 628515UDI EUDAMEDFDA UDI
- Description
- For Use with HLA-SSO Typing Kits FDA UDI
Identifiers
- Catalog Number
- 628515UDI FDA UDI
- Primary DI / UDI-DI
- 10888234500827 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823411W01030403C004JKH EUDAMED
- Direct Marketing DI
- 10888234500827 EUDAMED
- FDA Product Code
- MZI FDA UDI
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
Dilution Solution by Immucor GTI Diagnostics, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823411W01030403C004JKH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc
- EUDAMED SRN
- US-MF-000020921
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 2d48cfab-6ab5-4e07-b3d3-ceb63ce4b7be 61 fields · synced Jul 11, 2026
- FDA UDI 733df197-4145-40d6-bf1a-243fa59eec25 37 fields · synced May 30, 2026