Fujirebio Diagnostics, Inc.

Medical device contract manufacturer · Malvern, Pennsylvania, United States

Fujirebio Diagnostics, Inc. is a medical device contract manufacturer with a registered site in Malvern, Pennsylvania, United States. The US FDA lists 2 medical device sites registered to the company, with devices in clinical chemistry, immunology and clinical toxicology.

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Fujirebio Diagnostics at a glance

Typemedical device contract manufacturer

Registered siteMalvern, Pennsylvania, United States

FDA-registered sites2, plus sites in 3 other countries

What does Fujirebio Diagnostics do?

Medical specialties of its FDA-listed devices

Clinical ChemistryImmunologyClinical ToxicologyMicrobiologyObstetrics and GynecologyHematology

Device types listed with the FDA

Calibrator, secondarySingle (specified) analyte controls (assayed and unassayed)Test, epithelial ovarian tumor-associated antigen (ca125)Calibrators, drug specificCyclosporineSirolimus test systemSystem, test, immunological, antigen, tumorSystem, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer

Where is Fujirebio Diagnostics located?

Registered site: Malvern, Pennsylvania, United States

Malvern, PennsylvaniaFujirebio Diagnostics, Inc. · FDA device site
Seguin, TexasFujirebio Diagnostics, Inc. · FDA device site

International sites registered with the FDA

Mölndal, SwedenAihara, JapanGent, Belgium

Frequently asked questions about Fujirebio Diagnostics

Where is Fujirebio Diagnostics based?

Fujirebio Diagnostics, Inc. is based in Malvern, Pennsylvania, United States.

What does Fujirebio Diagnostics do?

Fujirebio Diagnostics, Inc. is a medical device contract manufacturer. Its FDA-listed medical devices fall under clinical chemistry, immunology and clinical toxicology.

How many FDA-registered sites does Fujirebio Diagnostics have?

The US FDA lists 2 registered sites for Fujirebio Diagnostics, Inc., plus sites in Sweden, Japan and Belgium.

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Last updated 2026-09-23. Data licences