IgG IG2448
IgG IG2448 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K955798 on 5 Apr 1996 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273203936), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055273203936 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK955798 | Date5 Apr 1996 | StatusActive |
Official records
- AccessGUDID record 05055273203936
- FDA 510(k) database K955798
Across registries
- FDA 510(k) K955798 decided 5 Apr 1996 Active
- FDA GUDID UDI-DI 05055273203936 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K955798
- Listed FDA GUDID 05055273203936
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IgG
- Generic name
- Total immunoglobulin G (IgG total) IVD, antibody
- Model / Ref / Catalog
- IG2448
- Primary DI / UDI-DI
- 05055273203936
- 510(k) Number
- FDA product code
- DEW
- GMDN term
- Total immunoglobulin G (IgG total) IVD, antibody
- Device class
- Class II
- Regulation number
- 866.5510
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DEW (Igg, Antigen, Antiserum, Control).
- IMMUNOLOGY CONTROL SERUM by Icl Scientific
- TIA-IGG REAGENT & CALIBRATOR SETS by Worthington Diagnostic Systems
- RADIAS FERRITIN ENZYME IMMUNOASSAY by Bio-Rad
- FLUOR. CONJUGATED ANTISERUM by KENT LABORATORIES, INC.
- J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI by J.T. Baker Chemical Co.
- FLUORESCEIN CONJUGATED ANTISERUM by KENT LABORATORIES, INC.
- WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD by Wako Chemicals USA, Inc.
- FITC GOAT ANTI-HUMAN IGG Y CHAIN by Gelco Diagnostics, Inc.
- DASP TM ANTI-RABBIT by Organon, Inc.
- QM300 IGG ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc.