FDA Registration
Active
🇰🇷 South Korea
Precision Biosensor Inc. 2nd Factory
Reg #: 3029916095
·
FEI: 3029916095
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Precision Biosensor Inc. 2nd Factory
- Registration Number
- 3029916095
- FEI Number
- 3029916095
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 310-11, Techno 2-ro
- City
- Yuseong-gu Daejeon
- Country
- KR
Owner / Operator
- Firm Name
- Precision Biosensor Inc.
- Operator Number
- 10050547
- Address
- 306, Techno 2-ro
- City
- Yuseong-gu
- State
- Daejeon
- Postal Code
- 34036
- Country
- KR
- Correspondent
- Jihyun Lee
US Agent
- Business Name
- Nano-Ditech Corporation
- Contact Name
- James Chang
- Address
- 259 Prospect Plains Rd Building K
- City
- Cranbury
- State
- NJ
- ZIP
- 08512
- Country
- US
- [email protected]
- Phone
- 609 4093300
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2018-12-10 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2017-01-19 |
| Fluorometer | JZT | Class 1 | Immunology | No | 2020-01-19 |
Proprietary Names
Fluoro-Checker TRF
Nano-Checker 710
Exdia TRF Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device