FDAnews Device Daily Bulletin

Mobidiag’s Molecular Test Gains CE Mark

Jan. 9, 2019

Finnish diagnostics developer Mobidiag earned the CE Mark for its Novodiag CarbaR+ test, which can detect bacteria that are resistant to carbapenem antibiotics.

The multiplex qPCR- and microarray-based test detects carbapenemase-producing enterobacteriaceae and provides results in 80 minutes through the company’s automated Novodiag system.

Mobidiag also has two other CE-marked antibiotic resistance screening tests, CarbaR+VRE and CarbaR+MCR, that are run on its Amplidiag multiplex system.

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