Identity
- Trade Name
- Care Touch FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- Blood Glucose Test strips FDA UDI
- Model / Reference
- CT-50 FDA UDI
- Description
- Blood Glucose Test strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00370393211056 FDA UDI
- 510(k) Number
- K111456 FDA UDI
- FDA Product Code
- CGA 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose IVD, kit, electrometry
Care Touch by Future Diagnostics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, kit, electrometry.
- VivaGuard Ino — Able Diagnostics Inc · Class I
- TruePoint — OK BIOTECH CO., LTD. · Class II
- VivaGuard Ino — Able Diagnostics Inc · Class II
- Easy Talk Blood Glucose Testing Strips 25ct — HOME AIDE DIAGNOSTICS, INC. · Class II
- FORA — FORA CARE INC. · Class II
- 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
Cleared under the same submission
K111456 also covers:
- CareLiving MM1100 Blood Glucose Meter — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Monitoring System — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Test Strips 100ct — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Test Strips 50ct — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Control Solution For Blood Glucose — CARE LIVING DIAGNOSTICS INC
- Care Touch — FUTURE DIAGNOSTICS LLC
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- Teco Diagnostics Glucopad Blood Glucose Test Strips — TECO DIAGNOSTICS
- CareTouch — Tianjin Empecs Medical Device Co., Ltd.
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
- Future Diagnostics Llc
Sources (1)
- FDA UDI 081df9ce-3f6c-4477-98ac-cc8d0515732a 35 fields · synced May 30, 2026