# Promega Biosystems Inc.

FEI: 3009311010
Status: Active
Establishment types: Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner/operator: Promega Corporation (#9036108)

Address: #1017 A Building Gangseo-Hangang-Xi Tower, 401 Yangcheon-ro, Gangseo-gu, Seoul, 07528, KR

Mandatory US Agent: PROMEGA CORPORATION

## Products

Total registered: 1
Top product codes: JJH
Regulation §: 862.2310

Proprietary names: Maxwell CSC Viral Total Nucleic Acid Purification Kit, Abbott mSample Preparation System, Maxwell CSC Pathogen Total Nucleic Acid Kit, Maxwell CSC Blood DNA Kit, Maxwell CSC RNA Blood Kit, Maxwell CSC RNA FFPE Kit, Maxwell® CSC Rapid ccfDNA Kit, Abbott mSample Preparation System DNA, Maxwell® CSC XtractAll FFPE DNA/RNA Kit, Maxwell CSC Instrument

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223009311010%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3009311010