FDA Registration
Active
🇰🇷 South Korea
GENECHECKER® UF-300 Real-time PCR System
Reg #: 3017644086
·
FEI: 3017644086
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENESYSTEM CO., LTD.
- Registration Number
- 3017644086
- FEI Number
- 3017644086
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200-9, Techno2-ro, Yuseong-gu, Daejeon, Republic of Korea
- City
- Daejeon
- Country
- KR
Owner / Operator
- Firm Name
- Genesystem Co., Ltd.
- Operator Number
- 10078631
- Address
- 200-9, Techno2-ro, Yuseong-gu, Daejeon, Republic of Korea
- City
- Daejeon
- State
- KR-30
- Postal Code
- 34028
- Country
- KR
- Correspondent
- Rayna Jung
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2020-10-29 |
Proprietary Names
GENECHECKER® UF-300 Real-time PCR System
WizDx F-150 Real-time PCR System
GENECHECKER® UF-340 Real-time PCR System
Establishment Types
Manufacture Medical Device