IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent EUDAMEDIMMAGE FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent EUDAMEDFDA UDI
- Model / Reference
- 446400 EUDAMEDFDA UDI
- Description
- IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent FDA UDI
Identifiers
- Catalog Number
- 446400 FDA UDI
- Primary DI / UDI-DI
- D-446400PM EUDAMED15099590223885 EUDAMEDFDA UDI
- Basic UDI-DI
- B-446400PM EUDAMED150995901446400KJ EUDAMED
- FDA Product Code
- CFN FDA UDI
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent by Beckman Coulter, Inc. — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-446400PM | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-446400PM | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (3)
- EUDAMED 27dd1fce-cb4d-412d-8cdd-391f77995cf5 61 fields · synced Oct 5, 2026
- EUDAMED 2cd82b0e-f9a2-42e0-bee5-1309b3a95ffa 61 fields · synced May 18, 2026
- FDA UDI e793fbfa-d168-4db1-bc37-980ff2183f1e 34 fields · synced May 30, 2026