Diagnostic Devices Inc.

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Web: http://www.prodigymeter.com
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Address: 9300 Harris Corners Parkway, Suite 450, Charlote, North Carolina 28269, USA
Phone: +1-(704)-285-6400, 800-366-5901 | Fax: +1-(704)-285-6477 | Map/Directions >>

Profile: Diagnostic Devices Inc. offers diabetes products. We specialize in designing a meter that caters to the needs of the blind and low vision diabetic. We provide blood glucose monitoring systems. Our Prodigy Voice™ is a blood glucose meter designed for the blind and low vision diabetic. Prodigy Autocode® is a blood glucose monitoring system. It avoids the danger of false results due to coding errors.

4 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.

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