RR Donnelley Global Turnkey Solutions

Web: http://www.rrdonnelley.com
Address: Manewrowa A 6/10, Lodz 92-517, Poland
Phone: +48-(42)-2740000 | Map/Directions >>

Profile: RR Donnelley Global Turnkey Solutions offers medical packaging solutions. We offer products such as medical devices, diagnostic kits, custom trays, blood glucose monitoring systems, blister packs and pouches.

The company is ISO 9001, ISO 13485 certified.

FDA Registration Number: 3013160357
US Agent: N/a / N/a

11 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.

• Contract Packaging

• 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 Glucose Dehydrogenase (FDA Code: LFR / 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.

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

• Medical Device Packaging Services

• Medical Packaging Services

• Medical Packagings

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

• Packaging

• Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435)

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.