FDA UDI
In Commercial Distribution
🇺🇸 United States
Cystatin C Controls
DI: 08058056685407
·
Model: 06T3210
·
SENTINEL CH. SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cystatin C Controls
- Primary DI
- 08058056685407
- Version / Model
- 06T3210
- Catalog Number
- 06T3210
- Company Name
- SENTINEL CH. SPA
- Labeler DUNS
- 429572365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-16
- Public Version
- 1
- Public Version Date
- 2025-09-24
- Public Version Status
- New
- Public Device Record Key
- 3cd0128c-ef09-4205-b69a-e0293db7be9f
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48175 | Cystatin C IVD, control | A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058056685407 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius