Identity
- Trade Name
- PTS Panels® HDL Cholesterol Test Strips FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
- Model / Reference
- 1714 FDA UDI
- Description
- PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Identifiers
- Catalog Number
- 1714 FDA UDI
- Primary DI / UDI-DI
- 00381931714014 FDA UDI
- FDA Product Code
- LBR FDA UDINAQ FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI862.1175 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
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
PTS Panels® HDL Cholesterol Test Strips by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060617 also covers:
K140068 also covers:
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct — Polymer Technology Systems
- CardioChek Plus Home eGLU Self-Test Strips — Polymer Technology Systems
- CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) — Polymer Technology Systems
- CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) — Polymer Technology Systems
- PTS Panels eGLU™ Glucose Test Strips (12-ct) — Polymer Technology Systems
- PTS Panels eGLU™ Glucose Test Strips (50-ct) — Polymer Technology Systems
- PTS Panels eGLU™ Test Strips — Polymer Technology Systems
- eGLU, 15ct., CCPlus Home — Polymer Technology Systems
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 dca27f79-a462-4537-9b5b-52750dd0dbcf 38 fields · synced Jun 8, 2026