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Gentian AS

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0099-2021Class IIGENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, CystaSeptember 2, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K081875GENTIAN CYSTATIN C IMMUNOASSAYAugust 20, 2008
K071388GENTIAN CYSTATIN C IMMUNOASSAYNovember 6, 2007