Identity
- Trade Name
- PTS Panels® Ketones Test Strips FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
- Model / Reference
- 1718 FDA UDI
- Description
- PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Identifiers
- Catalog Number
- 1718 FDA UDI
- Primary DI / UDI-DI
- 00381931718012 FDA UDI
- FDA Product Code
- JMK FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1380 FDA UDI
- Commercial Distribution
- Not 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
No
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
PTS Panels® Ketones Test Strips by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI df50c36b-adf2-4b1c-82b9-f240fe1fc1d8 37 fields · synced Jun 8, 2026