Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615837

FEI Number

3002608770

Entity Name

Fujirebio Europe N.V.

City/State/Country

GHENT Oost-Vlaanderen, BE

Establishment Address

TECHNOLOGIEPARK 6, GHENT Oost-Vlaanderen B-9052, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fujirebio Diagnostics, Inc. (Owner Number: 10022860)

Owner / Operator Contact Address

201 Great Valley Parkway, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P160016

All Registered Proprietary Names

Lumipulse B-Amyloid Plasma Controls Alinity i Methotrexate Controls (China) NSE [For use with] Alinity i Controls Atellica IM Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens Atellica IM Tumor Marker Quality Controls (TMQC) - Siemens Beckman PK-CMV PA Controls Lumipulse G BRAHMS PCT Controls Lumipulse ? Amyloid Controls Alinity i CYFRA 21-1 Controls (China) Alinity i Methotrexate Controls (ROW) Lumipulse pTau 217 Plasma Controls ARCHITECT Methotrexate Extended Range Controls (ROW) ARCHITECT CYFRA 21-1 Controls Alinity i Methotrexate Extended Range Controls (ROW) ARCHITECT CYFRA 21-1 Controls (China) NSE [For use with] Alinity i Controls (ROW) Alinity i CYFRA 21-1 Controls ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens NSE [For use with] ARCHITECT Controls Alinity i CYFRA 21-1 Controls (ROW) ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens ARCHITECT Methotrexate Extended Range Controls (China) Alinity i Methotrexate Extended Range Controls (China) NSE [For us with] ARCHITECT Controls (ROW) ARCHITECT CYFRA 21-1 Controls (ROW) ARCHITECT Thyroglobulin Controls Alinity i Thyroglobulin Controls TENDIGO Cat No. 80412 TENDIGO Disposable Trays Cat no. 80421 ADVIA Centaur XPT Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens ADVIA Centaur XPT Cytokeratin Fragment 21-1 (CYFRA) - Siemens Atellica IM Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens Atellica IM Cytokeratin Fragment 21-1 (CYFRA) - Siemens INNO-LiPA HCV 2 Genotyping 40T, IVD-US INNO-LiPA HCV 2 Control 6T, IVD-US INNO-LiPA HCV 2 Amp 40T, IVD-US INNO-LiPA HCV 2 Amp 100T, IVD-US INNO-LiPA HCV 2 Genotyping 100T, IVD-US LiRAS for LiPA HCV v1 IVD-US

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-12-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-12-19
OVK	Cytokeratin Fragments 21-1 Eia Kit	Immunology	Class 2	866.6010	2026-03-23
OBF	Assay, Genotyping, Hepatitis C Virus	Microbiology	Class 2	866.3170	2025-05-13

Official Correspondent

Greg Dickson

US Agent Details

Greg Dickson Business: Fujirebio Diagnostics, Inc. Email: dicksong@fdi.com Phone: (610) 2403888

Related Public Records

Same Entity

Fujirebio Diagnostics, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027273565	Fujirebio Diagnostics AB	Molndal Vastra Gotaland, SE
3000125561	Fujirebio Diagnostics, AB	Gothenburg Vastra Gotaland, SE
3014643041	Fujirebio Inc. Ube Facility	Yamaguchi, JP
1643621	Fujirebio Diagnostics, Inc.	Seguin, TX, US
3002895169	Fujirebio Inc.	Sagamihara-shi Kanagawa, JP

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.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615837. Last updated year: 2026. Please use registration number 9615837 when referencing this establishment in official correspondence.