← Back to catalogue
Anti-IgG, -C3d (Murine Monoclonal) +1 more model
EUDAMEDFDA UDIClass C (EU MDR)
Ref 0409703
Identity
- Trade Name
- Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone EUDAMEDAnti-IgG,-C3d (Polyspecific) (Murine Monoclonal) (Green) Gamma-clone FDA UDI
- Generic Name
- Monospecific anti-complement component C3d (anti-C3d) IVD, antibody FDA UDI
- Device Name
- Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone EUDAMEDThis product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is three (3) vials of reagent. The color of the liquid reagent is green. FDA UDI
- Model / Reference
- 0409703 EUDAMEDFDA UDI
- Description
- This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is three (3) vials of reagent. The color of the liquid reagent is green. FDA UDI
Identifiers
- Catalog Number
- 0409703 FDA UDI
- Primary DI / UDI-DI
- 10888234001676 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030304C000SB EUDAMED
- EMDN Code
- W0103030304 POLYSPECIFIC ANTIHUMAN SERUM EUDAMED
- GMDN Term
- Monospecific anti-complement component C3d (anti-C3d) IVD, antibody FDA UDI
- Models / Variants
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
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
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-IgG, -C3d (Murine Monoclonal) +1 more model by Immucor, Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models
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 | 88823401W0103030304C000SB | 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 f09a126b-d794-496d-8555-905e50663af6 61 fields · synced Jun 19, 2026
- FDA UDI 43f86486-31d1-4f83-a97a-7e1d3ac6ae32 35 fields · synced May 30, 2026