FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. Lipoprotein (a)
DI: 00811727011831
·
Model: L7597-CAL
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Scientific, Inc. Lipoprotein (a)
- Primary DI
- 00811727011831
- Version / Model
- L7597-CAL
- Catalog Number
- L7597-CAL
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e181712e-fbe3-4304-bdb4-a1b974879489
Device Description
Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis.
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 |
|---|---|---|---|---|
| 41417 | Lipoprotein A 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 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 | 00811727011831 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013359 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius