Identity
- Trade Name
- UniQ PINP RIA EUDAMEDUniQ® PINP RIA FDA UDI
- Generic Name
- Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- UniQ PINP RIA EUDAMEDUniQ® 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. FDA UDI
- Model / Reference
- 67034 EUDAMEDFDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 67034 FDA UDI
- Primary DI / UDI-DI
- 06438115000082 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438115000082 EUDAMED
- 510(k) Number
- K043125 FDA UDI
- FDA Product Code
- CIN FDA UDI
- EMDN Code
- W0102060317 PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE EUDAMED
- GMDN Term
- Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1050 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
UniQ PINP RIA by Aidian Oy — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438115000082 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (2)
- EUDAMED ad759678-d750-4fe7-8a31-11ed18dc905e 61 fields · synced Jul 31, 2026
- FDA UDI 518894c3-2a06-4e78-8ab9-2a18cb6ede20 37 fields · synced May 30, 2026