Identity
- Trade Name
- Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) FDA UDI
- Generic Name
- Multiple lipid analyte IVD, kit, spectrophotometry FDA UDI
- Device Name
- CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. FDA UDI
- Model / Reference
- REF 4752 FDA UDI
- Description
- CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. FDA UDI
Identifiers
- Catalog Number
- REF 4752 FDA UDI
- Primary DI / UDI-DI
- 00381934752013 FDA UDI
- FDA Product Code
- NBW FDA UDICGA FDA UDICHH FDA UDILBR FDA UDIJGY FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1175 FDA UDI862.1475 FDA UDI862.1705 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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 technologiesMultiple lipid analyte IVD, kit, spectrophotometry
Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple lipid analyte IVD, kit, spectrophotometry.
- CardioChek — HENRY SCHEIN, INC. · Class I
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct — Polymer Technology Systems · Class II
- Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home — Polymer Technology Systems · Class I
- CardioChek Plus Home Lipid Panel Self-Test Strip 2ct — Polymer Technology Systems · Class I
- Lipid Panel, 15ct., CCPlus Home — Polymer Technology Systems · Class I
- PTS Panels® Lipid Panel Test Strips — Polymer Technology Systems · Class I
- Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home — Polymer Technology Systems · Class I
- PTS Panels® Lipid Panel Test Strips (10-ct) — Polymer Technology Systems · Class I
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI d50a5f7c-b6b1-4df5-8e31-e7a1179462f8 36 fields · synced May 30, 2026