INFINITY™ Low Control Solution IGM-0024
INFINITY™ Low Control Solution IGM-0024 is a Class I device made by U.S. Diagnostics Inc., listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00885502015000), 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 | Number00885502015000 | Date24 Sep 2018 | StatusListed |
Official records
- AccessGUDID record 00885502015000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- INFINITY™ Low Control Solution
- Generic name
- Glucose IVD, control
- Model / reference
- IGM-0024
- Primary DI / UDI-DI
- 00885502015000
- FDA product code
- JJX
- GMDN term
- Glucose IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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