Gentian AS

Norway NO-MF-000003448 Last updated 25 Oct 2026

Catalogue19

Gentian Cystatin C Single Use Control Low 1029 Ref 1029

Class II FDA UDI
Gentian Cystatin C Single Use Control High 1030 Ref 1030

Class II FDA UDI
Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems Ref 1100 / A52761

Class B EUDAMEDFDA UDI Active
Gentian Cystatin C Immunoassay Ref K081875

Class II FDA 510(k) Active
Gentian Cystatin C Immunoassay Ref K071388

Class II FDA 510(k) Active
Gentian Cystatin C Control Kit Ref 1019

Class B EUDAMEDFDA UDI Active
GCAL®NEPH Controls Ref 1719

Class B EUDAMED Active
Gentian Cystatin C Reagent Kit for the Beckman Coulter AU Systems Ref 1103 / B08179

Class B EUDAMEDFDA UDI Active
Gentian GCAL® Calprotectin Reagent Kit S Ref 1202

Class B EUDAMED Active
Gentian Cystatin C Calibrator Ref 1012

Class B EUDAMEDFDA UDI Active
Gentian GCAL® Calprotectin Calibrator Kit Ref 1251

Class B EUDAMED Active
Gentian Cystatin C Calibrator Kit Ref 1051

Class B EUDAMEDFDA UDI Active
Gentian Cystatin C Reagent Kit Ref 1101

Class B EUDAMEDFDA UDI Active
Gentian Cystatin C Control Kit Ref 1019 / A52765

Class B EUDAMEDFDA UDI Active
GCAL®NEPH Calibrator Ref 1712

Class B EUDAMED Active
GCAL®NEPH Calprotectin Ref 1701

Class B EUDAMED Active
Gentian GCAL® Calprotectin Control Kit Ref 1219

Class B EUDAMED Active
Gentian Cystatin C Calibrator Kit Ref 1051 / A52763

Class B EUDAMEDFDA UDI Active
Gentian Cystain C Control Kit Ref 1026

Class B EUDAMEDFDA UDI Active

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2020
- 2 Sep 2020 Z-0099-2021 Class II Terminated The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.