FDA Registration
Active
🇰🇷 South Korea
Promega Biosystems Inc.
Reg #: 3009311010
·
FEI: 3009311010
·
Expires 2026
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- Promega Biosystems Inc.
- Registration Number
- 3009311010
- FEI Number
- 3009311010
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #1017 A Building Gangseo-Hangang-Xi Tower, 401 Yangcheon-ro, Gangseo-gu
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Promega Corporation
- Operator Number
- 9036108
- Address
- 2800 Woods Hollow Road, --
- City
- Madison
- State
- WI
- Postal Code
- 53711
- Country
- US
US Agent
- Business Name
- PROMEGA CORPORATION
- Contact Name
- Carol Lindsay
- Address
- 2800 Woods Hollow Road
- City
- Madison
- State
- WI
- ZIP
- 53711
- Country
- US
- [email protected]
- Phone
- 608 2744330 ext. 1330
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2011-04-05 |
Proprietary Names
Maxwell CSC RNA Blood Kit
Maxwell® CSC Rapid ccfDNA Kit
Maxwell CSC Instrument
Maxwell CSC DNA FFPE Kit
Maxwell CSC Genomic DNA Kit
Maxwell CSC Pathogen Total Nucleic Acid Kit
Abbott mSample Preparation System DNA
Maxwell CSC RNA FFPE Kit
Abbott mSample Preparation System
Maxwell CSC Whole Blood DNA Kit
Maxwell CSC 48 Instrument
Maxwell CSC Viral Total Nucleic Acid Purification Kit
Maxwell® CSC XtractAll FFPE DNA/RNA Kit
Maxwell CSC Blood DNA Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)