Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006801241

FEI Number

3006801241

Entity Name

Gentian AS

City/State/Country

Moss Ostfold, NO

Establishment Address

Bjornasveien 5, Moss Ostfold N-1596, NO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gentian AS (Owner Number: 10023325)

Owner / Operator Contact Address

15696 Oakstand Road, Poway, CA 92064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081875

PMA Number

N/A

All Registered Proprietary Names

Gentian Cystatin C Immunoassay Cystatin C Immunoassay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2007-11-16
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2008-09-23

Official Correspondent

No official correspondent registered.

US Agent Details

Eric S Gruff Business: E4 Consulting Email: eric@e4consult.com Phone: (858) 7350320

Related Public Records

Same Entity

Gentian AS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
2084025	KAMIYA BIOMEDICAL COMPANY LLC	Tukwila, WA, US
2032900	Diazyme Laboratories, Inc.	POWAY, CA, US
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006801241. Last updated year: 2026. Please use registration number 3006801241 when referencing this establishment in official correspondence.