Identity
- Trade Name
- Concentrated Wash EUDAMEDConcentrated Wash (10X) FDA UDI
- Generic Name
- HLA class I antibody screening IVD, reagent FDA UDI
- Device Name
- Concentrated Wash EUDAMEDFor Use with Factor VIII Antibody Screen and PakPlus FDA UDI
- Model / Reference
- 403622 EUDAMEDFDA UDI
- Description
- For Use with Factor VIII Antibody Screen and PakPlus FDA UDI
Identifiers
- Catalog Number
- 403622 FDA UDI
- Primary DI / UDI-DI
- 10888234500407 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823411W01030402C006BJS EUDAMED
- Direct Marketing DI
- 10888234500407 EUDAMED
- FDA Product Code
- MYP FDA UDI
- EMDN Code
- W01030402 HLA ANTIBODY SCREENING EUDAMED
- GMDN Term
- HLA class I antibody screening IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Concentrated Wash by Immucor GTI Diagnostics, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823411W01030402C006BJS | 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 4b20f104-f5f2-418c-a7aa-6d5e6987d920 61 fields · synced Jun 8, 2026
- FDA UDI 83bccd0b-f681-4a9e-8c13-74b5ff3c743e 37 fields · synced May 25, 2026