← Back to catalogue
CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct FDA UDI
- Generic Name
- Multiple lipid analyte IVD, kit, spectrophotometry FDA UDI
- Device Name
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnostic devices used to measure glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. FDA UDI
- Model / Reference
- 4721 FDA UDI
- Description
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnostic devices used to measure glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. FDA UDI
Identifiers
- Catalog Number
- 4721 FDA UDI
- Primary DI / UDI-DI
- 00381934721019 FDA UDI
- FDA Product Code
- CGA FDA UDIJGY FDA UDINBW FDA UDILBR FDA UDICHH FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1705 FDA UDI862.1475 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
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
CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple lipid analyte IVD, kit, spectrophotometry.
- CardioChek — HENRY SCHEIN, INC. · Class I
- 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
- Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) — Polymer Technology Systems · Class II
- 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
Cleared under the same submission
K022898 also covers:
K023558 also covers:
K140068 also covers:
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI 2d32b6ac-c3f0-4d91-adc2-498ea953d0cb 37 fields · synced May 29, 2026