FDA Registration
Active
🇰🇷 South Korea
AccuSaliva Collection Kit Dx
Reg #: 3013228421
·
FEI: 3013228421
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACCUGENE, INC.
- Registration Number
- 3013228421
- FEI Number
- 3013228421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 73, Gaetbeol-ro
- City
- Yeonsu-gu Incheon
- Country
- KR
Owner / Operator
- Firm Name
- AccuGene, Inc.
- Operator Number
- 10060292
- Address
- 73, Gaetbeol-ro
- City
- Yeonsu-gu
- State
- Incheon
- Postal Code
- 21999
- Country
- KR
- Correspondent
- Sun Jae Kwon
US Agent
- Business Name
- ACCUGENE USA INC
- Contact Name
- Sun Jae Kwon
- Address
- #150, 5050 Murphy Canyon Rd.
- City
- San Diego
- State
- CA
- ZIP
- 92123
- Country
- US
- [email protected]
- Phone
- 858 9239034
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-04-22 |
Proprietary Names
AccuSaliva Collection Kit Dx
AccuStool Collection Kit Dx
Establishment Types
Manufacture Medical Device