FDA UDI
In Commercial Distribution
🇺🇸 United States
UniQ® PINP RIA
DI: 06438115000082
·
Model: 67034
·
Aidian Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UniQ® PINP RIA
- Primary DI
- 06438115000082
- Version / Model
- 67034
- Catalog Number
- 67034
- Company Name
- Aidian Oy
- Labeler DUNS
- 401656868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-13
- Public Version
- 5
- Public Version Date
- 2020-03-02
- Public Version Status
- Update
- Public Device Record Key
- 518894c3-2a06-4e78-8ab9-2a18cb6ede20
Device Description
UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentration of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | Clinical Chemistry | 862.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61762 | Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of procollagen type I N-terminal propeptide (PINP) in a clinical specimen, using a radioimmunoassay method. PINP is an indicator of osteoblastic activity and used in the management of postmenopausal osteoporosis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438115000082 | GS1 |
Customer Contacts
- Phone
- +358103093000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043125 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius