Identity
- Trade Name
- CardioChek® Analyzer; Refurbished FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
- Device Name
- The CardioChek® Analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. FDA UDI
- Model / Reference
- 1782 FDA UDI
- Description
- The CardioChek® Analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. FDA UDI
Identifiers
- Catalog Number
- 1782 FDA UDI
- Primary DI / UDI-DI
- 00381931782013 FDA UDI
- 510(k) Number
- K014099 FDA UDI
- FDA Product Code
- CHH FDA UDIJGY FDA UDICGA FDA UDINBW FDA UDINGO FDA UDILBR FDA UDINAQ FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
- Models / Variants
- CardioChek® Analyzer FDA UDIRefurbished FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI862.1705 FDA UDI862.1345 FDA UDI862.1475 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® Analyzer +1 more model by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — 2 models — 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 — HENRY SCHEIN, INC. · Class I
- 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
- i-STAT — Abbott Point of Care Inc. · Class II
Cleared under the same submission
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 685be177-79f1-44dc-8c60-5db4d8afd95c 37 fields · synced Jun 1, 2026