Topical Issues

510(k) Premarket Notification

Since the beginning of 2017 CONGEN prepares the rebuilding and expansion for planed FDA approval.

We proudly announce, starting from now, the first kit for the detection of Norovirus genogroup get the 510(k) Premarket Notification (PMN). The FDA confirms that this device is at least as safe and effective as legally marketed devices.

The approval of further detection kits is in progress.

Moving of CONGEN ServiceLab

We would like to improve our service for you, due to this we expand our capacities of the CONGEN service laboratory. The service lab will move to another building on the campus in Berlin-Buch. The accreditation of the lab will not be affected.

Starting from 01.11.2017 please send all of your samples to following address:

CONGEN Biotechnologie GmbH ServiceLab

Haus 80

Robert-Rössle-Str. 10

13125 Berlin

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