Identity
- Trade Name
- Gamma ELU-KIT II EUDAMEDFDA UDI
- Generic Name
- Red cell antibody eluting IVD, kit FDA UDI
- Device Name
- Gamma ELU-KIT II EUDAMEDGamma ELU-KIT II is intended for use in the rapid acid elution of antibodies from intact red blood cells. FDA UDI
- Model / Reference
- 0007861 EUDAMEDFDA UDI
- Description
- Gamma ELU-KIT II is intended for use in the rapid acid elution of antibodies from intact red blood cells. FDA UDI
Identifiers
- Catalog Number
- 0007861 FDA UDI
- Primary DI / UDI-DI
- 10888234000860 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399C020015F EUDAMED
- FDA Product Code
- KSG FDA UDI
- EMDN Code
- W0103030399 ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - 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
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
Gamma ELU-KIT II 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 | 88823401W01030399C020015F | 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 515c6a50-f9bc-463b-9b3e-79ec61d07898 61 fields · synced Jul 17, 2026
- FDA UDI a9662536-7eb8-4c2f-b723-441bd2b36a78 37 fields · synced May 29, 2026