Data / Medical devices / Norway / Gentian AS
Gentian AS: FDA-registered device maker in Moss Ostfold, Norway, 2 510(k) clearances
Gentian AS is registered with the FDA (registration 3006801241) in Moss Ostfold, Norway. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2008. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006801241
- Address
- Bjornasveien 5, Moss Ostfold, Norway, N-1596
- Owner or operator
- Gentian AS (10023325)
- Roles
- Manufacturer
- First device listed
- November 16, 2007
- Registered through
- 2027
- Brand names listed
- Cystatin C Immunoassay, Gentian Cystatin C Immunoassay
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Test, Cystatin C | NDY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2008 | K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | NDY | Substantially Equivalent | Gentian AS | accessdata.fda.gov |
| November 6, 2007 | K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | NDY | Substantially Equivalent | Gentian AS | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 2, 2020 | 86465 | Class II | Terminated | GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)0 | 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. | accessdata.fda.gov |
Compare with other makers
Updated August 20, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.