Device typeFaecal specimen collection kit IVD, clinical: A collection of devices intended exclusively for professional use for the sampling and containment of a small, predetermined amount of faecal matter from a primary faecal specimen, for subsequent laboratory analysis and/or other investigation. It typically consists of a specimen container (e.g., tube with a cap) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium, extraction buffer), and a sampling tool (e.g., swab, brush or spatula). This is a single-use device.
FDA categoryCalprotectin, Fecal
Device ID08426950846833
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information