Gentian AS

Medical device manufacturer in Moss, Norw.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K081875Gentian Cystatin C ImmunoassayNDY · Special 08/20/2008SE
K071388Gentian Cystatin C ImmunoassayNDY · Traditional 11/06/2007SE

Recalls

RecallProductInitiated
Z-0099-2021 Class IIGENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C…The firm has identified lots of calibrators that have shown to measure incorrect high values over time… 09/02/2020Terminated