Identity
- Trade Name
- LIFECODES Wash Buffer EUDAMEDFDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- LIFECODES Wash Buffer EUDAMEDFor Use with LIFECODES LifeScreen Deluxe FDA UDI
- Model / Reference
- 628211 EUDAMEDFDA UDI
- Description
- For Use with LIFECODES LifeScreen Deluxe FDA UDI
Identifiers
- Catalog Number
- 628211 FDA UDI
- Primary DI / UDI-DI
- 10888234400516 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823411W01030402C002HJS EUDAMED
- Direct Marketing DI
- 10888234400516 EUDAMED
- FDA Product Code
- MZI FDA UDI
- EMDN Code
- W01030402 HLA ANTIBODY SCREENING EUDAMED
- GMDN Term
- Buffered wash solution 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Yes
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
LIFECODES Wash Buffer 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 | 88823411W01030402C002HJS | 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 d8a24d4b-60f0-4b30-b7c3-15686bc8b775 61 fields · synced Jun 18, 2026
- FDA UDI b26334f6-2dfb-41fb-bc55-3f6ba324ebbe 37 fields · synced May 30, 2026