Identity
- Trade Name
- FORA FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- Blood Glucose Test Strips FDA UDI
- Model / Reference
- GTel/Test N'GO Advance/Test N'GO Advance Voice/Test N'GO Adv. Mobile FDA UDI
- Description
- Blood Glucose Test Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816042015038 FDA UDI
- 510(k) Number
- K173505 FDA UDI
- FDA Product Code
- LFR FDA UDI
- GMDN Term
- Glucose IVD, kit, electrometry 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
Category: Glucose IVD, kit, electrometry
Fora by Fora Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, kit, electrometry.
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- OneTouch Ultra — Lifescan, Inc. · Class II
- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
- Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC. · Class II
- Prodigy No Coding Blood Glucose Test Strips — PRODIGY DIABETES CARE, LLC · Class II
Cleared under the same submission
K173505 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fora Care Inc.
Sources (1)
- FDA UDI c7917f3b-d845-40a2-b402-8c15b8bfafae 34 fields · synced May 30, 2026