FDA Device Establishments · JSON-LD · Markdown

Promega Biosystems Inc.

FEI 3009311010 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active

FEI Number3009311010
Owner / OperatorPromega Corporation (#9036108)
Address#1017 A Building Gangseo-Hangang-Xi Tower, 401 Yangcheon-ro, Gangseo-gu, Seoul, 07528, KR
Mandatory US AgentPROMEGA CORPORATION
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)JJH
Regulation § (21 CFR)862.2310
Proprietary namesMaxwell 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

External sources

Source: openFDA. Public-domain (CC0).