Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2521625

FEI Number

2521625

Entity Name

Fujirebio Diagnostics, Inc.

City/State/Country

Malvern, PA, US

Establishment Address

201 Great Valley Parkway, Malvern, PA 19355, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

All Registered Proprietary Names

VITROS CA 125II Calibrators VITROS CA125II Reagent ARCHITECT Methotrexate Reagents (ROW) Alinity i Methotrexate Reagents (ROW) Alinity i Methotrexate Reagents (China) ARCHITECT Methotrexate Reagents (China) ARCHITECT ROMA Alinity i ROMA 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 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 SARS-CoV-2 IgG assay (for use on ARCHITECT) SARS-CoV-2 IgG assay (for use on Alinity) ARCHITECT Sirolimus Calibrators (China) ARCHITECT Sirolimus Reagents (China) ARCHITECT Sirolimus Reagents ARCHITECT Sirolimus Whole Blood Precipitation Reagent Transplant Pretreatment Tubes 1P06 Alinity i Sirolimus Reagent Kit Alinity i Sirolimus Whole Blood Precipitation Reagent ARCHITECT Sirolimus Calibrators ARCHITECT Sirolimus Controls Alinity i Sirolimus Calibrtors (China) Alinity i Sirolimus Reagents (China) Alinity i Sirolimus Controls ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US) Alinity i Galectin-3 Reagents Alinity i Galectin-3 Calibrators Alinity i Galectin-3 Controls Alinity i Tacrolimus Reagents (China) ARCHITECT Tacrolimus Whole Blood Precipitation Reagent Transplant Pretreatment Tubes 1P06 Alinity i Tacrolimus Reagent ARCHITECT Tacrolimus Calibrators Alinity i Tacrolimus Whole Blood Precipitation Reagent ARCHITECT Calibrators (China) ARCHITECT Tacrolimus Reagents (China) Alinity i Tacrolimus Controls ARCHITECT Tacrolimus Alinity i Calibrators (China) VITROS CA15-3 VITROS CA 125 II Calibrator VITROS CA 125 II Reagent Pack VITROS PSA VITROS CA 15-3 Calibrators VITROS CA15-3 Reagent NSE [For use with] ARCHITECT Reagents Alinity i CYFRA 21-1 Reagents (China) ARCHITECT CYFRA 21-1 Reagents NSE [For use with] Alinity i Reagents Alinity i CYFRA 21-1 Reagents ARCHITECT CYFRA 21-1 Reagents (China) Lumipulse G ?-Amyloid Calibrators Lumipulse G ?-Amyloid Ratio (1-42/1-40) Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-42 Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-40 Alinity i CA 19-9XR Calibrators (China) Alinity i CA 19-9XR Reagents Alinity i CA 19-9XR Controls ARCHITECT CA 19-9XR Reagents (China) ARCHITECT CA 19-9XR Controls Alinity i CA 19-9XR Calibrators Alinity i CA 19-9XR Reagents (China) ARCHITECT CA 19-9XR Calibrators ARCHITECT CA 19-9XR Calibrators (China) ARCHITECT CA 19-9XR Reagents ARCHITECT HE4 Calibrators (China) ARCHITECT HE4 Reagents (ROW) ARCHITECT HE4 Controls (China) ARCHITECT HE4 Calibrators (ROW) Alinity i HE4 Calibrators ARCHITECT HE4 Controls (ROW) ARCHITECT HE4 Reagents ARCHITECT HE4 Calibrators ARCHITECT HE4 Controls Alinity i HE4 Controls Alinity i HE4 Reagents (China) Alinity i HE4 Reagents Alinity i HE4 Calibrators (China) Alinity i HE4 Controls (ROW) Alinity i HE4 Controls (China) ARCHITECT HE4 Reagents (China) Alinity i HE4 Reagents (ROW)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2007-10-17
LAO	Enzyme Immunoassay, Methotrexate	Unknown	Class U	N/A	2014-11-03
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	Class 2	866.6050	2016-07-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-12-05
SET	Immunoassay Blood Test For Amyloid Pathology Assessment	Immunology	Class 2	866.5840	2025-06-16
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-22
NRP	Sirolimus Test System	Clinical Toxicology	Class 2	862.3840	2007-10-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-10-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-12-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-30
OSX	Galectin-3 In Vitro Diagnostic Assay	Clinical Chemistry	Class 2	862.1117	2014-12-30
MLM	Enzyme Immunoassay, Tracrolimus	Clinical Chemistry	Class 2	862.1678	2007-10-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-10-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-17
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2026-02-10
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2007-10-17
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2007-10-17
OVK	Cytokeratin Fragments 21-1 Eia Kit	Immunology	Class 2	866.6010	2013-01-17
QSE	AlzheimerS Disease Pathology Assessment Test	Immunology	Class 2	866.5840	2022-05-25
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2007-10-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-10-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-03-23
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-03-23
OIU	Test, Epithelial Ovarian Tumor Associated Antigen (He4)	Immunology	Class 2	866.6010	2010-03-23

Official Correspondent

Greg Dickson

US Agent Details

No US Agent registered (Local establishment).

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
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-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

Similar Registrations

Registration Number	Establishment Name	Location
9612316	TOSOH AIA, INC.	TOYAMA, JP
3014643041	Fujirebio Inc. Ube Facility	Yamaguchi, JP
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
2122870	BECKMAN COULTER, INC.	CHASKA, MN, US
8031673	TOSOH CORP.	Chuo-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2521625. Last updated year: 2026. Please use registration number 2521625 when referencing this establishment in official correspondence.