Fujirebio Diagnostics, INC

201 Great Valley Pkwy, Malvern, PA 19355

ACTIVELAST SEEN IN FEDERAL DATA OCT 2026 · 4 SOURCES

Operating signal within 12 months from two or more independent sources.

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Their homepage, crawled JUL 2026

What they make

In-Vitro Diagnostic Substance Manufacturing325413

vitro diagnostics
contract development
manufacturing organization
CDMO
biomarker innovation

NAMED ON THE COMPANY’S OWN WEBSITE, READ JUL 29, 2026

Products

Made or handled here · 20

AlzheimerS Disease Pathology Assessment Test · Calibrators, Drug Specific · Calibrator, Secondary · Cyclosporine · Cytokeratin Fragments 21-1 Eia Kit · Enzyme Immunoassay, Methotrexate · Enzyme Immunoassay, Tracrolimus · Galectin-3 In Vitro Diagnostic Assay · Immunoassay Blood Test For Amyloid Pathology Assessment · Ovarian Adnexal Mass Assessment Score Test System · Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers · Reagent, Coronavirus Serological · Single (Specified) Analyte Controls (Assayed And Unassayed) · Sirolimus Test System · System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer · System, Test, Immunological, Antigen, Tumor · System, Test, Thyroglobulin · Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) · Test, Epithelial Ovarian Tumor Associated Antigen (He4) · Test, Natriuretic Peptide

Where these came from

20 from FDA device registration · Federal registry

FDA device establishment 2521625, product code QSE; proprietary names: Lumipulse G ?-Amyloid Ratio (1-42/1-40), Lumipulse G ?-Amyloid Immunoreaction Cartridges 1-40, Lumipulse G ?-

CAREERS

Careers page — seen SEP 8, 2026

Where it is

40.06042, -75.54512 · CENSUS TIGER

COUNTY

Chester County

METRO AREA

Philadelphia-Camden-Wilmington, PA-NJ-DE-MD

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Other plants nearby

Facility	City	Industry	Status	Distance
Fujirebio Diagnostics Inc., Malvern	Malvern	In-Vitro Diagnostic Substance Manufacturing 325413	LIKELY ACTIVE	0.0 KM
US004 PA Malvern	Malvern	Pharmaceutical Preparation Manufacturing 325412	LIKELY ACTIVE	0.1 KM
Puresyn, INC.	Malvern	Pharmaceutical Preparation Manufacturing 325412	ACTIVE	0.5 KM
Janssen Biotech INC	Malvern	Pharmaceutical Preparation Manufacturing 325412	UNVERIFIED	0.5 KM
Endo Usa, INC.	Malvern	Pharmaceutical Preparation Manufacturing 325412	ACTIVE	0.9 KM

Every listed plant in Chester County

Also at this address

No other federal record shares this street address.

Where this record comes from

4 sources hold this plant, and 9 fields on this page come from them. Each line is one agency’s own record of it: the identifier it is filed under, whether that record shows the plant operating or only that it exists, and when the register first and last saw it there.

EPA cross-references this facility in NPDES, PA-EFACTS, RCRAINFO · EPA site type STATIONARY.

FDA device establishment registrationsOPERATING
first seen AUG 2026 · last seen OCT 2026
The company’s own websiteOPERATING
first seen JUL 2026 · last seen OCT 2026
SAM.gov entity registrationOPERATING
Record ZELGEGMQPJX7 · first seen FEB 2026 · last seen OCT 2026
EPA Facility Registry ServiceEXISTENCE
Record 110027983911 · first seen JAN 2016 · last seen JAN 2016

IN CHESTER COUNTY25 other plants share this one’s industry (Pharmaceutical and Medicine Manufacturing, NAICS 3254); 9 of them have a size band on record.

What each source says

Every field below, as each source filed it. The value this page shows is marked; where the sources disagree, the field says so. Status is computed from independent sources; nothing here is self-reported unless marked Claimed.

Name: EPA: FUJIREBIO DIAGNOSTICS INC · JUL 2026 · ON THIS PAGE; SAM.gov: FUJIREBIO DIAGNOSTICS, INC · ON THIS PAGE
Street address: EPA: 201 GREAT VALLEY PKWY · JUL 2026 · ON THIS PAGE; SAM.gov: 201 GREAT VALLEY PKWY · ON THIS PAGE
City: EPA: MALVERN · JUL 2026 · ON THIS PAGE; SAM.gov: MALVERN · ON THIS PAGE
State: EPA: PA · JUL 2026 · ON THIS PAGE; SAM.gov: PA · ON THIS PAGE
County (FIPS code): EPA: 42029 · SEP 2026
CoordinatesSOURCES DISAGREE: Census geocoder: 40.060419369649,-75.545120329464 · JUL 2026 · ON THIS PAGE; EPA: 40.06092,-75.54255 · JUL 2026
Website: SAM.gov: www.fujirebio.com
CAGE code: SAM.gov: 1U5D9
SAM registration expires: SAM.gov: 2027-02-03

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