Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010534606

FEI Number

3010534606

Entity Name

DIAGENODE s.a.

City/State/Country

Seraing Liege, BE

Establishment Address

Rue du Bois Saint Jean 3, Seraing Liege 4102, BE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Diagenode s.a. (Owner Number: 10079757)

Owner / Operator Contact Address

Rue du Bois Saint Jean 3, Seraing, BE-WLG 4102, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MG Macrolide Resistance Probes MG Macrolide Resistance Primers Mycoplasma genitalium Macrolide Resistance IVT A2059G Control Mycoplasma genitalium Macrolide Resistance IVT A2059C Control Mycoplasma genitalium Macrolide Resistance IVT A2058G Control Mycoplasma genitalium Macrolide Resistance IVT A2058T Control Mycoplasma genitalium Macrolide Resistance IVT A2058C Control Mycoplasma genitalium IVT WT Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2020-12-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-12-23

Official Correspondent

Geraldine Poncin

US Agent Details

Jeffrey Hergesheimer Business: Hologic Inc. Email: jeffrey.hergesheimer@hologic.com Phone: (858) 4108536

Related Public Records

Same Entity

Diagenode s.a.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
3012104694	EUROFINS GENOMICS LLC	Louisville, KY, US
1124976	SUPERTECHS, INC.	Gaithersburg, MD, US
3011873748	AUGUREX LIFE SCIENCES CORP	Vancouver British Columbia, CA
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK
3004375571	GLYCOMINDS DIAGNOSTICS (2014) LTD.	Raanana Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010534606. Last updated year: 2026. Please use registration number 3010534606 when referencing this establishment in official correspondence.