Identity
- Trade Name
- Specimen Diluent EUDAMEDFDA UDI
- Generic Name
- Cell preservation/storage/dilution solution IVD FDA UDI
- Device Name
- Specimen Diluent EUDAMEDSpecimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is six (6) vials of 57 mL volume. FDA UDI
- Model / Reference
- 0066053 EUDAMEDFDA UDI
- Description
- Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is six (6) vials of 57 mL volume. FDA UDI
Identifiers
- Catalog Number
- 0066053 FDA UDI
- Primary DI / UDI-DI
- 10888234001072 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399A0000045 EUDAMED
- FDA Product Code
- KSZ FDA UDI
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
- GMDN Term
- Cell preservation/storage/dilution solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
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
Specimen Diluent by Immucor, 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 | 88823401W01030399A0000045 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 6103db59-0699-48be-9928-877775111ec8 61 fields · synced Jul 12, 2026
- FDA UDI 19919d41-dbf6-44c3-aba2-0496e4bd84ec 37 fields · synced May 30, 2026