Identity
- Trade Name
- CYSTATIN C CALIBRATOR (CYSC CAL) FDA UDI
- Generic Name
- Cystatin C IVD, calibrator FDA UDI
- Device Name
- Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. FDA UDI
- Model / Reference
- CYS10445 FDA UDI
- Description
- Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. FDA UDI
Identifiers
- Catalog Number
- CYS10445 FDA UDI
- Primary DI / UDI-DI
- 05055273216882 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Cystatin C IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
Cystatin C Calibrator (cysc Cal) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cystatin C IVD, calibrator.
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- ADVIA Cystatin C_2 Calibrator — Siemens Healthcare Diagnostics · Class II
- Cystatin C Calibrators — Sentinel Ch. Srl · Class II
- Atellica CH CYSC_2 Calibrators — Siemens Healthcare Diagnostics · Class II
- C.f.a.s. Cystatin C — Roche Diagnostics Corp. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 5de6d032-f47f-4bdf-b3cf-29fa1afa9486 36 fields · synced Jun 8, 2026