Identity
- Trade Name
- INFINITY™ Meter Kit FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Model / Reference
- IGM-0024 FDA UDI
Identifiers
- Catalog Number
- G5-103MK FDA UDI
- Primary DI / UDI-DI
- 00885502001003 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 0.5 Microliter FDA UDI
Category: Glucose monitoring system IVD, home-use
INFINITY™ Meter Kit by U.s. Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- U.s. Diagnostics Inc.
Sources (1)
- FDA UDI 11cedb29-7f3e-4b6a-a9d3-32c74ed7af1e 36 fields · synced May 30, 2026