Identity
- Trade Name
- PTS Panels® Cholesterol Test Strips FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
- Model / Reference
- 1711 FDA UDI
- Description
- PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Identifiers
- Catalog Number
- 1711 FDA UDI
- Primary DI / UDI-DI
- 00381931711013 FDA UDI
- 510(k) Number
- K981493 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 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: Total cholesterol lipid IVD, kit, rapid colorimetric, clinical
PTS Panels® Cholesterol 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 |
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Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI b22a8606-4cce-4891-8fad-bfccbc21c0b6 37 fields · synced May 30, 2026