Identity
- Trade Name
- PTS Panels® Glucose Test Strips (25-ct) FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
- Model / Reference
- 1713 FDA UDI
- Description
- PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Identifiers
- Catalog Number
- 1713 FDA UDI
- Primary DI / UDI-DI
- 00381931713017 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care 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
Yes
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
No
FDA UDI
Category: Glucose monitoring system IVD, point-of-care
PTS Panels® Glucose Test Strips (25-ct) by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Polymer Technology Systems
Sources (1)
- FDA UDI 420f70b2-183d-4ada-9cc7-9e3b2358e62c 36 fields · synced May 31, 2026