Tyson Bioresearch, Inc.

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Contact: Wen-Hai Tsai
Web: http://web.tysonbio.com
E-Mail:
Address: 5 F, No. 22, Ke East Road III, Science-Based Industrial Park, Chu-Nan 350, Taiwan
Phone: +886-(37)-585988 | Fax: +886-(37)-585996 | Map/Directions >>

Profile: Tyson Bioresearch, Inc. specializes in in-vitro, immuno diagnostic test systems and electrical bio-sensing systems. Our Vigor is a blood glucose monitoring system with 4 user setting reminder alarms, high & low reading settings, PC download options and alternative site testing option. Our Quikpac one step HIV-1/2 test is an immuno chromatographic assay for qualitative determination of antibodies against human immunodeficiency virus types 1 and 2. The test utilizes recombinant viral antigens and yields visually read results in fifteen minutes. The sample for the test is whole blood, plasma or serum.

The company is ISO 9001, ISO 13485 certified.

FDA Registration Number: 3003132490
US Agent: Diane Furnari / Mdi Consultants, Inc.
Phone: +1-(516)-482-9001 Fax: +1-(516)-482-0186 E-Mail:

5 Products/Services (Click for related suppliers)

• 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.

• Blood Collection Lancet (FDA Code: FMK / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Data Processing Module for Clinical use (FDA Code: JQP / 862.2100)

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.

• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345)

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345)