FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasmaproteins Cal 3x
DI: 08058056681300
·
Model: A26854
·
SENTINEL CH. SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Plasmaproteins Cal 3x
- Primary DI
- 08058056681300
- Version / Model
- A26854
- Catalog Number
- A26854
- Company Name
- SENTINEL CH. SPA
- Labeler DUNS
- 429572365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2682a975-64d0-420c-bd35-b1048885c251
Device Description
Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic 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
- No
- 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 |
|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30505 | Plasma protein IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058056681300 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081533 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 2 and 8 degrees Celsius