Alpha-Tec Systems

Device typeFaecal specimen collection kit IVD, home-use: A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

FDA categorySolution, Formalin-Sodium Acetate

Device ID00816085022833

Catalog number0003363

Single useYes

MRI safetyLabeling does not contain MRI Safety Information