Identity
- Trade Name
- IgG FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
- Device Name
- The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma FDA UDI
- Model / Reference
- IG2448 FDA UDI
- Description
- The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma FDA UDI
Identifiers
- Catalog Number
- IG2448 FDA UDI
- Primary DI / UDI-DI
- 05055273203936 FDA UDI
- 510(k) Number
- K955798 FDA UDI
- FDA Product Code
- DEW FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, antibody 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: Total immunoglobulin G (IgG total) IVD, antibody
IgG by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total immunoglobulin G (IgG total) IVD, antibody.
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- Tinto IgG, RPab — BIO SB, INC. · Class I
- IgG RMab — BIO SB, INC. · Class I
- IHC — Slmp, LLC · Class I
- FLEX Poly Rb A-Hu IgG RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
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 4967510a-d1d4-48a8-bb88-1f4db6cce43f 37 fields · synced Jun 8, 2026