Identity
- Trade Name
- Cystatin C Controls FDA UDI
- Generic Name
- Cystatin C IVD, control FDA UDI
- Device Name
- The Cystatin C Controls are for the estimation of test precision and the detection of systematic analytical deviations 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
- 06T3210 FDA UDI
- Description
- The Cystatin C Controls are for the estimation of test precision and the detection of systematic analytical deviations 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
- 06T3210 FDA UDI
- Primary DI / UDI-DI
- 08058056685407 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
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, control
Cystatin C Controls by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cystatin C IVD, control.
- CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) — Randox Laboratories, Ltd. · Class I
- Diazyme — Diazyme Laboratories, Inc.
- CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) — Randox Laboratories, Ltd. · Class I
- CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Cystatin C Control Set Gen.2 — Roche Diagnostics Corp. · Class I
- CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) — Randox Laboratories, Ltd. · Class I
- Audit MicroControls Linearity LQ Cystatin C — Aalto Scientific, Ltd.
- Validate — LGC Clinical Diagnostics, Inc. · Class I
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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 3cd0128c-ef09-4205-b69a-e0293db7be9f 36 fields · synced May 30, 2026