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Teco Diagnostics Glucopad Blood Glucose Test Strips
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics Glucopad Blood Glucose Test Strips FDA UDI
- Generic Name
- Glucose IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Glucopad Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood (from fingertip, forearm, and palm) with the Glucopad Blood Glucose Meter. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. FDA UDI
- Model / Reference
- Glucopad Blood Glucose Test Strips FDA UDI
- Description
- Teco Diagnostics Glucopad Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood (from fingertip, forearm, and palm) with the Glucopad Blood Glucose Meter. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. FDA UDI
Identifiers
- Catalog Number
- G852-B-002 FDA UDI
- Primary DI / UDI-DI
- 10673486000726 FDA UDI
- 510(k) Number
- K111456 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Glucose IVD, reagent 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Glucose IVD, reagent
Teco Diagnostics Glucopad Blood Glucose Test Strips by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, reagent.
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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
- Care Touch — FUTURE DIAGNOSTICS LLC
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- TECO DIAGNOSTICS — 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
- Teco Diagnostics
Sources (1)
- FDA UDI 57132297-3f5a-4cc6-90f6-6db64a262eda 37 fields · synced Jun 6, 2026