Fujirebio Diagnostics Inc

Click Here To EMAIL INQUIRY
Web: http://www.fdi.com
E-Mail:
Address: 201 Great Valley Pkwy, Malvern, Pennsylvania 19355, USA
Phone: +1-(610)-240-3800 | Fax: +1-(610)-240-3825 | Map/Directions >>

Profile: Fujirebio Diagnostics Inc specializes in diagnostic products. Our product is used to detect the presence of cancer in the blood and sugar.

The company was founded in 1998, has revenues of USD 25-50 Million, has ~100 employees and is ISO 9001, CE certified.

FDA Registration Number: 2521625

46 Products/Services (Click for related suppliers)

• Alcohol Control Materials (FDA Code: DKC / 862.3280)

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• 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.

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660)

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Automated Blood Grouping and Antibody Test System (FDA Code: KSZ / 864.9175)

An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

• Blood Bank Test Kits

• Carbohydrate Antigen (Ca19-9) Test System For Monitoring And Management Of Pancreatic Cancer (FDA Code: NIG / 866.6010)

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

• Carbohydrate Antigen Test

• Clinical Diagnostics Solutions

• Cortisol Fluorometric Test (FDA Code: JFT / 862.1205)

A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

• Cyclosporine (FDA Code: MKW / 862.1235)

A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.

• Cyclosporine and Metabolites Serum Assay (FDA Code: MAR / 862.1235)

• Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS / 862.1235)

• Drug Mixture Control Materials (FDA Code: DIF / 862.3280)

• Drug Specific Calibrator (FDA Code: DLJ / 862.3200)

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

• ELISA Kit for Soluble Mesothelin-Related Peptides

• Enzyme Immunoassay

• Enzyme Immunoassay Kits

• Epithelial Ovarian Tumor Associated Antigen (He4) Test (FDA Code: OIU / 866.6010)

• Epithelioid/Biphasic Mesothelioma, Soluble Mesothelin-Related Peptides Cancer Monitoring Test System (FDA Code: OAW)

• Escherichia Coli Antigens (FDA Code: GMZ / 866.3255)

• Fecal Occcult Blood Enzymatic Method

• Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU / 862.1235)

• Histology Test Kits

• Infectious Disease Identification Test Kits

• Instruments, Immunoassays

• Manual Radioimmunoassay Kits

• Monoclonal Antibodies

• Multi Analyte Control (FDA Code: JJY / 862.1660)

• Natriuretic Peptide Test (FDA Code: NBC / 862.1117)

The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

• OEM Custom Solutions

• Ovarian Tumor-Associated Antigen(Ca 125) Test (FDA Code: LTK / 866.6010)

• Passive Particle Agglutination Tests

• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 866.6010)

• Quality Control Kit for Blood Banking Reagents (FDA Code: KSF / 864.9650)

A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.

• Rabies Virus Fluorescent Antiserum Test (FDA Code: GOI / 866.3460)

Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed by animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.

• RIA Instruments

• Secondary Calibrator (FDA Code: JIT / 862.1150)

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Sirolimus Test System (FDA Code: NRP / 862.3840)

A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.

• Syphilis Test

• Tacrolimus Enzyme Immunoassay (FDA Code: MLM / 862.1678)

A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.

• Temperature Discrimination Test (FDA Code: LQW / 882.1200)

• 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.

• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870)

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

• Treponemal Antigens Syphilis Donor Test (FDA Code: MYR / 866.3830)

• Tumor Antigen Immunological Test System (FDA Code: MOI / 866.6010)