Identity
- Trade Name
- IgG FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- IG3896 FDA UDI
Identifiers
- Catalog Number
- IG3896 FDA UDI
- Primary DI / UDI-DI
- 05055273203967 FDA UDI
- 510(k) Number
- K955798 FDA UDI
- FDA Product Code
- DEW FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
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
Category: Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
IgG by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry.
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- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Human IgG3 SPA PLUS Bulk Kit — The Binding Site Group · Class II
- Optilite IgG1 Kit — The Binding Site Group · Class II
- Alinity — Abbott · Class II
Cleared under the same submission
K955798 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 39593eb2-00e0-47e9-859e-6a91b5b8c25c 34 fields · synced Jun 6, 2026