← Back to catalogue
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent
EUDAMEDFDA UDIClass C (EU MDR)
Ref 0004817
Identity
- Trade Name
- Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent EUDAMEDAnti-k (Monoclonal) (IgG) Gamma-clone FDA UDI
- Generic Name
- Anti-k (KEL002) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Anti-k (Monoclonal) (IgG) Gamma-clone EUDAMEDAnti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial. FDA UDI
- Model / Reference
- 0004817 EUDAMEDFDA UDI
- Description
- Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial. FDA UDI
Identifiers
- Catalog Number
- 0004817 FDA UDI
- Primary DI / UDI-DI
- 10888234002390 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030501C104SR EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
- GMDN Term
- Anti-k (KEL002) red blood cell grouping IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMED
- 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
Yes
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
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
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent by Immucor, Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 88823401W0103030501C104SR | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 8ee83764-150d-4d65-96fd-22d07cde8a81 61 fields · synced Oct 5, 2026
- FDA UDI f50c4007-dc9b-4b3d-9542-b4850a896665 35 fields · synced May 30, 2026