Identity
- Trade Name
- Anti-Kpb - Blood Grouping Reagent EUDAMEDAnti-Kpb FDA UDI
- Generic Name
- Anti-Kp^b red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Anti-Kpb Blood Grouping Reagent EUDAMEDThis reagent is used for the detection of the Kpb antigen on red blood cells by tube test. This product configuration is a single vial. FDA UDI
- Model / Reference
- 0007550 EUDAMEDFDA UDI
- Description
- This reagent is used for the detection of the Kpb antigen on red blood cells by tube test. This product configuration is a single vial. FDA UDI
Identifiers
- Catalog Number
- 0007550 FDA UDI
- Primary DI / UDI-DI
- 10888234000785 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030501C201SQ EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
- GMDN Term
- Anti-Kp^b 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
Yes
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-Kpb - Blood Grouping Reagent 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 | 88823401W0103030501C201SQ | 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 9daffafd-22ea-457d-bf54-9cc09b404342 61 fields · synced Jul 15, 2026
- FDA UDI 784938aa-c11c-4064-a116-aaf398f53fba 35 fields · synced May 30, 2026