Identity
- Trade Name
- B-Ketone Control Solution FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- Our B-Ketone Control Solution is intended for use to ensure your meter and test strips are working together properly. Use with EKF Diagnostics' B-Ketone Test Strips only. FDA UDI
- Model / Reference
- 7024-204 FDA UDI
- Description
- Our B-Ketone Control Solution is intended for use to ensure your meter and test strips are working together properly. Use with EKF Diagnostics' B-Ketone Test Strips only. FDA UDI
Identifiers
- Catalog Number
- 7024-204 FDA UDI
- Primary DI / UDI-DI
- 00657498002278 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Multiple clinical chemistry analyte monitoring system IVD, home-use
B-Ketone Control Solution by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.
- FORA — FORA CARE INC. · Class II
- FORA — FORA CARE INC. · Class II
- KetoSens — i-SENS, Inc. · Class I
- KetoSens — i-SENS, Inc. · Class I
- FreeStyle Lite — ABBOTT DIABETES CARE INC · Class II
- Blood Ketone Control solution(level 3) — e-Linkcare Meditech Co., Ltd · Class I
- FreeStyle Precision Neo — ABBOTT DIABETES CARE INC · Class II
- FreeStyle Precision Neo — ABBOTT DIABETES CARE INC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 797ee340-6932-4b43-95c7-423fbd178bf1 36 fields · synced May 30, 2026