FDA UDI
In Commercial Distribution
🇺🇸 United States
Lp(a) Ultra
DI: 08058056680211
·
Model: 11504D
·
SENTINEL CH. SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lp(a) Ultra
- Primary DI
- 08058056680211
- Version / Model
- 11504D
- Catalog Number
- 11504D
- Company Name
- SENTINEL CH. SPA
- Labeler DUNS
- 429572365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-15
- Public Version
- 1
- Public Version Date
- 2024-03-25
- Public Version Status
- New
- Public Device Record Key
- 426f19a1-c2a2-47c2-b269-303b81dfaf5e
Device Description
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.
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 |
|---|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | Immunology | 866.5600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53442 | Lipoprotein A IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of lipoprotein A lipid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058056680211 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211058 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 2 and 8 degrees Celsius