Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002895169

FEI Number

3002895169

Entity Name

Fujirebio Inc.

City/State/Country

Sagamihara-shi Kanagawa, JP

Establishment Address

1-3-14 Tanashioda, Chuo-ku, Sagamihara-shi Kanagawa 252-0245, 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

K153145

PMA Number

N/A

All Registered Proprietary Names

Syphilis Control Set Lumipulse Infectious Diseases Controls Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Lumipulse G B-Amyloid 1-42-N Plasma IC Lumipulse G B-Amyloid 1-42-N Plasma Calibrators Lumipulse G pTau 217 Plasma Calibrators Lumipulse G pTau 217 Plasma IC LUMIPULSE G BRAHMS PCT Calibrator Set LUMIPULSE G BRAHMS PCT IRC 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 Lumipulse G TP-N Calibrators Lumipulse G TP-N IC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2017-02-10
SET	Immunoassay Blood Test For Amyloid Pathology Assessment	Immunology	Class 2	866.5840	2025-06-16
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2018-04-02
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2018-04-02
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2018-04-02
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
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2016-07-29

Official Correspondent

No official correspondent registered.

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
3014643041	Fujirebio Inc. Ube Facility	Yamaguchi, JP
1643621	Fujirebio Diagnostics, Inc.	Seguin, TX, US

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 3002895169. Last updated year: 2026. Please use registration number 3002895169 when referencing this establishment in official correspondence.