Identity
- Trade Name
- Chemcard Cholesterol FDA UDI
- Generic Name
- Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-test FDA UDI
- Device Name
- The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only. FDA UDI
- Model / Reference
- 43001 FDA UDI
- Description
- The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00737051548303 FDA UDI
- 510(k) Number
- K864159 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-test FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 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
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, colorimetric, rapid, professional/self-test
Chemcard Cholesterol by Chematics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Chematics, Inc.
Sources (1)
- FDA UDI b4b86a7b-00d8-42ef-9c85-2deee67e0390 36 fields · synced Jun 6, 2026