Fujirebio, Inc.

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Contact: Paul Touhey - President
Web: http://www.fujirebiodiagnostics.com
E-Mail:
Address: 201 Great Valley Parkway, Malvern 19355-1, Japan
Phone: +1-(610)-240-3800, 877-861-7246 | Fax: +1-(610)-240-3949 | Map/Directions >>

Profile: Fujirebio Diagnostics, Inc. deals with the production of in vitro diagnostics and biomarkers. We specialize in the manufacturing of manual assay products and reagents. Some of our manufacturing services & capabilities include cell culture , antibody & antigen purification, bulk liquid processing, protein labeling (radioactive & non-radioactive) and aseptic filling. The CA125™ is a tumor marker for ovarian cancer. It is indicated for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic follow-up procedures.

The company is ISO 9001:2000, ISO 13485:2003, ISO 14001 certified.

FDA Registration Number: 8031611
US Agent: Greg Dickson / Fujirebio Diagnostics, Inc.
Phone: +1-(610)-240-3888 Fax: +1-(610)-240-3820 E-Mail:

3 Products/Services (Click for related suppliers)

• Angiotensin Converting Enzyme Radioassay (FDA Code: KQN / 862.1090)

An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.

• Thyroglobulin (FDA Code: DDC / 866.5870)

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• Treponema Pallidum HA Antigen (FDA Code: GMT / 866.3830)