Identity
- Trade Name
- Gamma EGA Kit EUDAMEDFDA UDI
- Generic Name
- Red cell antibody eluting IVD, kit FDA UDI
- Device Name
- Gamma EGA Kit EUDAMEDGamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing. FDA UDI
- Model / Reference
- 0007865 EUDAMEDFDA UDI
- Description
- Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing. FDA UDI
Identifiers
- Catalog Number
- 0007865 FDA UDI
- Primary DI / UDI-DI
- 10888234000877 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399C020025H EUDAMED
- FDA Product Code
- KSG FDA UDI
- EMDN Code
- W0103030299 RHESUS TYPING ASSAYS OTHER EUDAMED
- GMDN Term
- Red cell antibody eluting IVD, kit FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9600 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
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
Gamma EGA Kit by Immucor, Inc. — Class C — 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 | 88823401W01030399C020025H | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | 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 e88bd22e-e8e2-4c02-8491-6a7b41155d1b 61 fields · synced Jul 21, 2026
- FDA UDI cf049be4-49fd-4005-8bc8-977a2407103e 37 fields · synced May 29, 2026