Apex Biotechnology Corp.

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Web: http://www.apexbio.com
E-Mail:
Address: NO.7, Li-Hsin Road.V, Hsin-Chu science park, Hsin-Chu, Taiwan, China
Phone: +886-(3)-5641952 | Fax: +886-(3)-5678302 | Map/Directions >>

Profile: Apex Biotechnology Corp. specializes in developing biosensor-based blood glucose monitoring system. Our product line includes multi-functional monitoring system, blood glucose monitoring system, blood cholesterol monitoring system, blood uric acid monitoring system, blood lactate monitoring system, hemoglobin screening system and pesticide residue detection system.Our multi-functional monitoring system is available in two types such as multisure and multisure GC. Our multisure meter tests both glucose and uric acid. It is fast & accurate and has one button operation. Our product contains test strips, auto lancing device, monitor checker, battery, code card, wallet, user guide and log book. Our blood cholesterol monitoring system is of three types such as multisure GC, Cholsure and cholsure blood cholesterol test strip.

FDA Registration Number: 9616936
US Agent: Tomspeikers / Arkray Usa, Inc.
Phone: +1-(952)-646-3168 Fax: +1-(952)-646-3110 E-Mail:

6 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.

• 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.

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450)

A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850)

A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

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