FDA Registration
Active
🇫🇮 Finland
QuikRead go CRP
Reg #: 9610102
·
FEI: 3002807786
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- AIDIAN OY
- Registration Number
- 9610102
- FEI Number
- 3002807786
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KOIVU-MANKKAAN TIE 6B
- City
- ESPOO Uusimaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K142993
Owner / Operator
- Firm Name
- AIDIAN OY
- Operator Number
- 9062384
- Address
- Koivu-Mankkaan tie 6 B, --
- City
- Espoo
- State
- FI-NOTA
- Postal Code
- 02200
- Country
- FI
- Correspondent
- Viivi - Almira
US Agent
- Business Name
- Princeton BioMeditech Corporation
- Contact Name
- Kim Young-A
- Address
- 4242 US Highway 1
- City
- Monmouth Jct
- State
- NJ
- ZIP
- 08852
- Country
- US
- [email protected]
- Phone
- 732 2741000 ext. 111
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2016-05-30 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2016-05-30 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-05-30 |
Proprietary Names
QuikRead go CRP
QuikRead go Instrument
QuikRead go CRP Verification Set
QuikRead go CRP Control Set
Establishment Types
Manufacture Medical Device