Fujirebio Diagnostics, Inc.

Registration Details

Registration Name: Fujirebio Diagnostics, Inc.
Registration Number: 1643621
FEI Number: 1643621
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 940 Crossroads Blvd
City: Seguin
State: TX
ZIP: 78155
Country: US

Regulatory Submissions

510(k) Number: K820499

Owner / Operator

Firm Name: Fujirebio Diagnostics, Inc.
Operator Number: 10022860
Address: 201 Great Valley Parkway
City: Malvern
State: PA
Postal Code: 19355
Country: US
Correspondent: Greg Dickson

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Antiserum, Fluorescent, Rabies Virus	GOI	Class 2	Microbiology	No	2007-10-17
Sirolimus Test System	NRP	Class 2	Clinical Toxicology	No	2007-10-17
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2007-10-17
Antigens, Ha, Treponema Pallidum	GMT	Class 2	Microbiology	No	2007-10-17
System, Test, Automated Blood Grouping And Antibody	KSZ	Class 2	Hematology	No	2008-05-30
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2016-04-19
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	Class 2	Immunology	No	2016-04-19
Calibrators, Drug Specific	DLJ	Class 2	Clinical Toxicology	No	2008-11-17
Cyclosporine	MKW	Class 2	Clinical Chemistry	No	2008-11-17
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2018-12-05
Enzyme Immunoassay, Tracrolimus	MLM	Class 2	Clinical Chemistry	No	2007-10-17
Multi-Analyte Controls Unassayed	OHQ	Class 1	Clinical Chemistry	No	2017-02-10

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 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 Alinity i Tacrolimus Reagents (China) ARCHITECT Tacrolimus Whole Blood Precipitation Reagent 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) Syphilis Control Set Lumipulse Infectious Diseases Controls

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)