Identity
- Trade Name
- Assy Vial, eGLU, 13 ct. FDA UDI
- Generic Name
- Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose 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
- REF 2488 FDA UDI
- Description
- The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose 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
- REF 2488 FDA UDI
- Primary DI / UDI-DI
- 00381932488013 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
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
Assy Vial, eGLU, 13 ct. by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple lipid analyte IVD, kit, multiple technologies.
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- CardioChek — HENRY SCHEIN, INC. · Class II
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- eGLU, 15ct., CCPlus Home — Polymer Technology Systems · Class II
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- PTS Panels eGLU™ Test Strips — Polymer Technology Systems · Class II
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 |
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Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI ac2f86ca-e9ef-41f0-9f60-7cb3d058af40 36 fields · synced Jun 8, 2026