Identity
- Trade Name
- TRUE FOCUS FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- TRUE FOCUS Control Solution Level 2 FDA UDI
- Model / Reference
- TRUE FOCUS Control Solution Level 2 FDA UDI
- Description
- TRUE FOCUS Control Solution Level 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00021292008437 FDA UDI
- 510(k) Number
- K131013 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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, control
True Focus by Trividia Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, control.
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- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
- ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
- Assure® Prism Control Solution — ARKRAY USA, INC. · Class I
- FORA — FORA CARE INC. · Class I
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
Cleared under the same submission
K131013 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 I | Pending data |
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Manufacturer
- Manufacturer
- Trividia Health, Inc.
Sources (1)
- FDA UDI 1ca3018b-4eb7-422c-b3f5-6b1a89b67afa 36 fields · synced Jun 8, 2026