Identity
- Trade Name
- ChekMate™ Strips FDA UDI
- Generic Name
- Glucose/ketone/lipid profile IVD, calibrator FDA UDI
- Device Name
- ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms. FDA UDI
- Model / Reference
- 860 FDA UDI
- Description
- ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms. FDA UDI
Identifiers
- Catalog Number
- 860 FDA UDI
- Primary DI / UDI-DI
- 00381930860019 FDA UDI
- 510(k) Number
- K151530 FDA UDI
- FDA Product Code
- CHH FDA UDICGA FDA UDILBR FDA UDIJGY FDA UDI
- GMDN Term
- Glucose/ketone/lipid profile IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI862.1345 FDA UDI862.1475 FDA UDI862.1705 FDA UDI
- Commercial Distribution
- Not 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
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
ChekMate™ 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 a6e7d522-4721-4187-96e5-a5c878e0ba94 38 fields · synced Jun 8, 2026