Identity
- Trade Name
- Tyson Bio HT100 Control Solution Level 3 FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Model / Reference
- HT100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719869701954 FDA UDI
- 510(k) Number
- K170079 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose IVD, control 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
No
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
Tyson Bio HT100 Control Solution Level 3 by Tyson Bioresearch, Inc. — Class II — 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
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Cleared under the same submission
K170079 also covers:
- Tyson Bio 50H Blood Glucose Test Strip, 10T — TYSON BIORESEARCH INC.
- Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC.
- Tyson Bio 50H Control Solution (Level 1) — TYSON BIORESEARCH INC.
- Tyson Bio 50H Control Solution (Level 2) — TYSON BIORESEARCH INC.
- Tyson Bio 50H Control Solution (Level 3) — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Blood Glucose Test Strips — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Blood Glucose Test Strips — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Control Solution (Level 2) — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Control Solution (Level 3) — TYSON BIORESEARCH INC.
- Tyson Bio HT100 Blood Glucose Meter — TYSON BIORESEARCH INC.
- Tyson Bio HT100 Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
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
- Tyson Bioresearch, Inc.
Sources (1)
- FDA UDI 35b64a51-b00d-4f5d-9ef4-e63a52b15384 33 fields · synced May 30, 2026