Identity
- Trade Name
- CardioChek FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
- Device Name
- CardioChek Plus Analyzer FDA UDI
- Model / Reference
- 5700411 FDA UDI
- Description
- CardioChek Plus Analyzer FDA UDI
Identifiers
- Catalog Number
- 5700411 FDA UDI
- Primary DI / UDI-DI
- 00304040037713 FDA UDI
- 510(k) Number
- K140068 FDA UDI
- FDA Product Code
- CHH FDA UDIJGY FDA UDILBR FDA UDINBW FDA UDICGA FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI862.1705 FDA UDI862.1475 FDA UDI862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyser IVD, point-of-care
CardioChek by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyser IVD, point-of-care.
- Afinion™ 2 — Abbott Diagnostics Technologies AS · Class I
- Alere Afinion™ AS100 — Abbott Diagnostics Technologies AS · Class I
- i-STAT — Abbott Point of Care Inc. · Class II
- CardioChek® Plus Professional Analyzer — Polymer Technology Systems · Class II
- CardioChek Plus Home Self-Test Analyzer — Polymer Technology Systems · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
Cleared under the same submission
K140068 also covers:
- 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 70e8306b-253e-4eb0-aa8b-8f259464e279 36 fields · synced Jun 1, 2026