Identity
- Trade Name
- Blood Ketone Control solution(level 3) FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you are performing the test correctly. FDA UDI
- Model / Reference
- CM211 FDA UDI
- Description
- It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you are performing the test correctly. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971404131604 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyte monitoring system IVD, home-use
Blood Ketone Control solution(level 3) by e-Linkcare Meditech Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Blood Glucose Control Solution — STANBIO LABORATORY, L.P. · 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
- e-Linkcare Meditech Co., Ltd
Sources (1)
- FDA UDI b2fd8dac-745f-4386-ad92-763ba0fa4e27 33 fields · synced May 30, 2026