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Red Blood Cell (RBC) Storage Solution
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0005036
Identity
- Trade Name
- Red Blood Cell (RBC) Storage Solution EUDAMEDFDA UDI
- Generic Name
- Cell preservation/storage/dilution solution IVD FDA UDI
- Device Name
- Red Blood Cell (RBC) Storage Solution EUDAMEDRed Blood Cell (RBC) Storage Solution is a general purpose reagent intended for use in suspending and preserving red blood cells that can be subsequently used for in vitro immunohematology testing. Red Blood Cell (RBC) Storage Solution is a buffered preservation solution containing adenosine and adenine to retard hemolysis and/or loss of antigenicity. The product is a one (1) liter bag configuration. FDA UDI
- Model / Reference
- 0005036 EUDAMEDFDA UDI
- Description
- Red Blood Cell (RBC) Storage Solution is a general purpose reagent intended for use in suspending and preserving red blood cells that can be subsequently used for in vitro immunohematology testing. Red Blood Cell (RBC) Storage Solution is a buffered preservation solution containing adenosine and adenine to retard hemolysis and/or loss of antigenicity. The product is a one (1) liter bag configuration. FDA UDI
Identifiers
- Catalog Number
- 0005036 FDA UDI
- Primary DI / UDI-DI
- 10888234000495 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399A0000147 EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Cell preservation/storage/dilution solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 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
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Red Blood Cell (RBC) Storage Solution 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 | 88823401W01030399A0000147 | 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 63eabdde-68d5-4bf5-9ae4-ce1f464f5e5d 61 fields · synced Jul 16, 2026
- FDA UDI 9c6a2af8-03b2-4010-aa08-a11ae43351f2 36 fields · synced May 30, 2026