Identity
- Trade Name
- PTS Panels® CHOL+HDL Test Strips FDA UDI
- Generic Name
- Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- PTS Panels® CHOL+HDL test strips are in vitro diagnostic devices used to monitor HDL cholesterol and total cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
- Model / Reference
- 1821 FDA UDI
- Description
- PTS Panels® CHOL+HDL test strips are in vitro diagnostic devices used to monitor HDL cholesterol and total cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Identifiers
- Catalog Number
- 1821 FDA UDI
- Primary DI / UDI-DI
- 00381931821019 FDA UDI
- 510(k) Number
- K162282 FDA UDI
- FDA Product Code
- LBR FDA UDICHH FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI862.1175 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: Multiple lipid analyte IVD, kit, multiple technologies
PTS Panels® CHOL+HDL Test Strips by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple lipid analyte IVD, kit, multiple technologies.
- CardioChek — HENRY SCHEIN, INC. · Class I
- CardioChek — HENRY SCHEIN, INC. · Class I
- CardioChek — HENRY SCHEIN, INC. · Class II
- CardioChek — HENRY SCHEIN, INC. · Class II
- PTS Panels® CHOL+Glu Test Strips — Polymer Technology Systems · Class I
- eGLU, 15ct., CCPlus Home — Polymer Technology Systems · Class II
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct — Polymer Technology Systems · Class II
- PTS Panels eGLU™ Test Strips — Polymer Technology Systems · Class II
Cleared under the same submission
K162282 also covers:
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 78089730-8689-41be-bbe7-93643cb5d86d 37 fields · synced May 30, 2026