Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014643041

FEI Number

3014643041

Entity Name

Fujirebio Inc. Ube Facility

City/State/Country

Yamaguchi, JP

Establishment Address

203-152, Aza-Ushiake, Oaza-Yoshiwa, Ube-shi, Yamaguchi 759-0134, JP

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

BK200476

PMA Number

N/A

All Registered Proprietary Names

Lumipulse G CA125II Calibrators Lumipulse G CA125II IC Lumipulse G Wash Solution 4008248 Lumipulse G1200 Instrument Lumipulse G Wash Solution 231173 Substrate Solutions Lumipulse G Dilution Cartridges Soda Lime for Lumipulse System Specimen Diluent 1 Serodia TP-PA Serodia TP-PA Kits 234952 Serodia TP-PA Kits 234976 PK CMV-PA System PK CMV-PA System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-04-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-04-19
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2016-04-19
GMT	Antigens, Ha, Treponema Pallidum	Microbiology	Class 2	866.3830	2007-10-17
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2008-05-30
MZE	Test, Donor, Cmv	Unknown	Class 2	N/A	2021-03-26

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
9615837	Fujirebio Europe N.V.	GHENT Oost-Vlaanderen, BE
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
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014643041. Last updated year: 2026. Please use registration number 3014643041 when referencing this establishment in official correspondence.