Identity
- Trade Name
- BioTel Care® Test Strips FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution. FDA UDI
- Model / Reference
- TS FDA UDI
- Description
- Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution. FDA UDI
Identifiers
- Catalog Number
- TT0003 FDA UDI
- Primary DI / UDI-DI
- 00859519002018 FDA UDI
- 510(k) Number
- K110571 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose monitoring system IVD, home-use
BioTel Care® Test Strips by Telcare, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Telcare, Llc
Sources (1)
- FDA UDI 4c0058ed-a483-465d-9dd1-88039351f5dd 37 fields · synced May 30, 2026