The OneDraw™ A1C Test System is a single-use, sterile, capillary blood specimen collection, stabilization, and transportation system. The device incorporates lancets to make two small incisions in the skin and a vacuum to draw blood at the surface of the skin and through channels to deposit the blood onto collection and stabilization matrices. The collection kit is designed to facilitate in vitro laboratory testing of blood samples for clinical chemistry assays. OneDraw™ includes a collection device, transport sleeve, accessories, and instructions needed to collect, package, and mail the sample collection cartridge to the certified clinical laboratory for HbA1c testing.
An assembly of devices intended to be used for the collection, preservation, and/or transportation of capillary blood for subsequent analysis and/or other investigation. It is a self-contained unit consisting of micro-needles and a container with a pre-measured amount of vacuum. The device is intended to be placed against the skin where the needles make shallow perforations, from which blood is drawn from the capillaries into the container via the vacuum. It may or may not contain a preservative or anticoagulant (e.g., lithium heparin). This is a single-use device.
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