Identity
- Trade Name
- CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) FDA UDI
- Generic Name
- Cystatin C IVD, control FDA UDI
- Device Name
- Intended for in vitro diagnostic (IVD) use in quality control of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. FDA UDI
- Model / Reference
- CYS10447 FDA UDI
- Description
- Intended for in vitro diagnostic (IVD) use in quality control of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. FDA UDI
Identifiers
- Catalog Number
- CYS10447 FDA UDI
- Primary DI / UDI-DI
- 05055273216905 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cystatin C 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: Cystatin C IVD, control
Cystatin C Control - Level 3 (cysc Control 3) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Yumizen C1200 L2 Cystatin C Control — Horiba Abx · Class I
- Yumizen C1200 L1 Cystatin C Control — Horiba Abx · Class I
- Diazyme — Diazyme Laboratories, Inc.
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 71c51a59-61d7-4ff5-a2e5-668ca6ac5cb4 36 fields · synced Jun 1, 2026