Fujirebio Diagnostics, INC

201 Great Valley Pkwy, Malvern, PA 19355

ACTIVELAST SEEN IN FEDERAL DATA AUG 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

Fujirebio develops in vitro diagnostic (IVD) biomarkers and provides contract development and manufacturing organization (CDMO) services. The company uses its Lumipulse® platform to validate diagnostic innovations and serves the diagnostics industry, with particular focus on neurological conditions including Alzheimer's disease.

SUMMARIZED FROM THE COMPANY’S OWN WEBSITE

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 ?-

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	LIKELY ACTIVE	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 FEDERAL SOURCES, 8 FIELDS

Every fact on this page traces to a public federal filing. The table below names which register holds this facility, whether that register proves the plant operates or only that it exists, and when each of them last saw it.

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

Source	Evidence	First seen	Last seen
FDA DEVICES	OPERATING	AUG 2026	AUG 2026
COMPANY SITE	OPERATING	JUL 2026	AUG 2026
SAM GOV	OPERATING	FEB 2026	FEB 2026
EPA FRS	EXISTENCE	JAN 2016	JAN 2016

FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT

FIELD	SOURCE	SIGNAL
ADDRESS LINE1	EPA FRS	JUL 2026
ADDRESS LINE1	SAM GOV	FEB 2026
CAGE CODE	SAM GOV	FEB 2026
CITY	EPA FRS	JUL 2026
CITY	SAM GOV	FEB 2026
GEOM	CENSUS GEOCODER	JUL 2026
GEOM	EPA FRS	JUL 2026
NAME	EPA FRS	JUL 2026
NAME	SAM GOV	FEB 2026
REGISTRATION EXPIRATION	SAM GOV	FEB 2026
STATE	EPA FRS	JUL 2026
STATE	SAM GOV	FEB 2026
WEBSITE	SAM GOV	FEB 2026

Status is computed from independent sources; nothing here is self-reported unless marked Claimed.

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