Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1643621

FEI Number

1643621

Entity Name

Fujirebio Diagnostics, Inc.

City/State/Country

Seguin, TX, US

Establishment Address

940 Crossroads Blvd, Seguin, TX 78155, US

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

N/A

All Registered Proprietary Names

FITC Anti-Rabies Monoclonal Globulin 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 Serodia TP-PA Serodia TP-PA Kits 234952 Serodia TP-PA Kits 234976 PK CMV-PA System 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 ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Transplant Pretreatment Tubes 1P06 ARCHITECT Cyclosporine Calibrators ARCHITECT Cyclosporine Alinity i Cyclosporine Whole Blood Precipitation Reagent Alinity i Cyclosporine Calibrators Alinity i Cyclosporine Reagent Emit Cyclosporine Sample Pretreatment Reagent 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GOI	Antiserum, Fluorescent, Rabies Virus	Microbiology	Class 2	866.3460	2007-10-17
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
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
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
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-11-17
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2008-11-17
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2020-05-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-12-05

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
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

Similar Registrations

Registration Number	Establishment Name	Location
3008344661	ABBOTT IRELAND	SLIGO, IE
2521625	Fujirebio Diagnostics, Inc.	Malvern, PA, US
2517506	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NEWARK, DE, US
1415939	ABBOTT LABORATORIES	Abbott Park, IL, US
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1643621. Last updated year: 2026. Please use registration number 1643621 when referencing this establishment in official correspondence.