FDA Registration
Active
🇰🇷 South Korea
Seegene STARlet
Reg #: 3008937712
·
FEI: 3008937712
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Seegene Inc.
- Registration Number
- 3008937712
- FEI Number
- 3008937712
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Taewon Building, 91, Ogeum-ro
- City
- Songpa-gu Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Seegene Inc.
- Operator Number
- 10060570
- Address
- Taewon Building, 91, Ogeum-Ro
- City
- Songpa-gu
- State
- Seoul
- Postal Code
- 05548
- Country
- KR
- Correspondent
- SeJung Hong
US Agent
- Business Name
- Seegene USA, Inc.
- Contact Name
- Jun Yong Ha
- Address
- 141 Innovation Dr
- City
- Irvine
- State
- CA
- ZIP
- 92617
- Country
- US
- [email protected]
- Phone
- 800 7252167
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2019-05-28 |
Proprietary Names
Seegene STARlet
STARMag 96x4 Universal Cartridge Kit
Seegene NIMBUS
STARMag 96x4 Universal Plus Cartridge Kit
STARMag 96 X 4 Viral DNA/RNA 200 C Kit
STARMag M96 Kit
Establishment Types
Manufacture Medical Device