Identity
- Trade Name
- Complement Control Cells EUDAMEDFDA UDI
- Generic Name
- Complement components C3/C3c IVD, control FDA UDI
- Device Name
- Complement Control Cells EUDAMEDComplement Control Cells are used in confirming reactivity of the anti-C3 component of Anti-Human Globulin, as a control mechanism for the antiglobuilin test. This product is a one (1) vial configuration. FDA UDI
- Model / Reference
- 0007930 EUDAMEDFDA UDI
- Description
- Complement Control Cells are used in confirming reactivity of the anti-C3 component of Anti-Human Globulin, as a control mechanism for the antiglobuilin test. This product is a one (1) vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0007930 FDA UDI
- Primary DI / UDI-DI
- 10888234000914 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030401C200S5 EUDAMED
- FDA Product Code
- KSF FDA UDI
- EMDN Code
- W0103030401 COOMBS CONTROL CELLS EUDAMED
- GMDN Term
- Complement components C3/C3c IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9650 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
Yes
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
Complement Control Cells 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 | 88823401W0103030401C200S5 | 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 a3e89ff2-ef9c-4255-91db-d9514a1b8b80 61 fields · synced Jul 16, 2026
- FDA UDI 3d0e8e84-5503-484d-a1ba-f932a2265e59 36 fields · synced May 30, 2026