Identity
- Trade Name
- IgG EUDAMEDAU FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IgG EUDAMEDFDA UDI
- Model / Reference
- OSR61172 EUDAMEDFDA UDI
- Description
- IgG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590011581 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995901OSR61172SZ EUDAMED
- 510(k) Number
- K073490 FDA UDI
- 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 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
No
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
IgG by Beckman Coulter, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995901OSR61172SZ | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 (2)
- EUDAMED 63c5d44b-322b-4008-8bc6-7f4bc2c6807b 61 fields · synced Oct 6, 2026
- FDA UDI 25bfb7bc-9241-4e55-90b6-b7cd7ec967cc 34 fields · synced May 29, 2026