INFINITY™ Starter Kit IGM-0024
INFINITY™ Starter Kit IGM-0024 (G5-003SK) is a Class II device made by U.S. Diagnostics Inc., listed in FDA GUDID since 13 Jan 2017 (UDI-DI 00885502000006), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00885502000006 | Date13 Jan 2017 | StatusListed |
Official records
- AccessGUDID record 00885502000006
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- INFINITY™ Starter Kit
- Generic name
- Glucose monitoring system IVD, home-use
- Model / Ref / Catalog
- IGM-0024, G5-003SK
- Primary DI / UDI-DI
- 00885502000006
- FDA product code
- CGA, NBW
- GMDN term
- Glucose monitoring system IVD, home-use
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 0.5 Microliter
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