Identity
- Trade Name
- FORA FDA UDI
- Generic Name
- Glucose/ketone/lipid monitoring system IVD, home-use FDA UDI
- Device Name
- Total Cholesterol Test System FDA UDI
- Model / Reference
- Test N'GO Advance FDA UDI
- Description
- Total Cholesterol Test System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816042014161 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Glucose/ketone/lipid monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose/ketone/lipid monitoring system IVD, home-use
Fora by Fora Care Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose/ketone/lipid monitoring system IVD, home-use.
- CURO L5 — KPI HEALTHCARE, INC. · Class II
- Curo L5 — KPI HEALTHCARE, INC. · Class I
- CURO L5 Total Cholesterol Strips — KPI HEALTHCARE, INC. · Class II
- FORA — FORA CARE INC. · Class I
- FORA — FORA CARE INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Fora Care Inc.
Sources (1)
- FDA UDI 7104ed05-c146-46af-a58a-6dbe1d6bc1ce 33 fields · synced May 30, 2026