IgG IG7158
IgG IG7158 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 05055273203974), 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 | Number05055273203974 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK955798 | Date5 Apr 1996 | StatusActive |
Official records
- AccessGUDID record 05055273203974
- FDA 510(k) database K955798
Across registries
- FDA 510(k) K955798 decided 5 Apr 1996 Active
- FDA GUDID UDI-DI 05055273203974 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K955798
- Listed FDA GUDID 05055273203974
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- Withdrawn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
- IG7158
- Primary DI / UDI-DI
- 05055273203974
- 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
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