Identity
- Trade Name
- Cystatin C Calibrators FDA UDI
- Generic Name
- Cystatin C IVD, calibrator FDA UDI
- Device Name
- The Cystatin C Calibrators are for the calibration of the Alinity c system when used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma. For additional information, refer to the Cystatin C reagent package insert and the Alinity ci-series Operations Manual. For laboratory professional use only. FDA UDI
- Model / Reference
- 06T3201 FDA UDI
- Description
- The Cystatin C Calibrators are for the calibration of the Alinity c system when used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma. For additional information, refer to the Cystatin C reagent package insert and the Alinity ci-series Operations Manual. For laboratory professional use only. FDA UDI
Identifiers
- Catalog Number
- 06T3201 FDA UDI
- Primary DI / UDI-DI
- 08058056685391 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
No
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 Calibrators by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cystatin C IVD, calibrator.
- K-ASSAY® Cystatin C Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- CYSTATIN C CALIBRATOR (CYSC CAL) — Randox Laboratories, Ltd. · Class II
- Yumizen C1200 Cystatin C Cal — Horiba Abx · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Dako — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ADVIA Cystatin C_2 Calibrator — Siemens Healthcare Diagnostics · Class II
- CYSC CAL — Randox Laboratories, Ltd. · Class II
- Atellica CH CYSC_2 Calibrators — Siemens Healthcare Diagnostics · 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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI b6c7b112-876d-4776-812d-9917fdf8b741 36 fields · synced May 30, 2026