Manufacturer

Promega

United StatesLegal entities : Promega Corporation

Markets : France · Germany · Ireland · Italy · Poland · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 1 · PMA : 2 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Poland 17 · France 7 · Italy 2 · Germany 1 · Ireland 1

EU representative : MDSS GmbH (Germany)

3 categories, 14 models including 14 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Robotic sample processing systems - consumables	W02060185	Maxwell® CSC Blood DNA Kit AS1321 Maxwell® CSC DNA FFPE Kit AS1350 Maxwell® CSC Genomic DNA Kit AS1850 Maxwell® CSC Pathogen Total Nucleic Acid Kit AS1860 Maxwell® CSC Rapid ccfDNA Kit AS1580 5 others Maxwell® CSC RNA Blood Kit AS1410 Maxwell® CSC RNA FFPE Kit AS1360 Maxwell® CSC Viral Total Nucleic Acid Purification Kit AS1780 Maxwell® CSC Whole Blood DNA Kit AS1820 Maxwell® CSC XtractAll FFPE DNA/RNA Kit AS1560	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Abbott mSample Preparation System 04J70-24 Abbott mSample Preparation SystemDNA 06K12-24	A IVDR	EUDAMED record Report an error
Robotic sample processing systems - hardware accessories	W02060180	Maxwell® CSC 48 Instrument AS8000 Maxwell® CSC Instrument AS6000	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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