Identity
- Trade Name
- TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3) FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Device Name
- This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. FDA UDI
- Model / Reference
- CQ3100 FDA UDI
- Description
- This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273201840 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple cardiac marker IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 cardiac marker IVD, control
TRI-LEVEL CARDIAC CONTROL - crd Control 1 by Randox Laboratories, Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 3 models
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI aee7d787-0874-482b-8625-bbc0f99ac5b5 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026