Procise Stool Collection Kit

Primary DI

08100322949130

Basic UDI-DI Code

081003229PDXE491222VJ

Reference

4913

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

ProciseDx Inc.

Each Procise Stool Collection Multipack Box (Ref 4913) contains twenty (20) Procise Stool Collection Kits (Ref 4912). The Procise Stool Collection Kit includes a proprietary specimen collection device and receptacle containing extraction buffer. The stool collection kit is designed for patient self-collection of a human stool sample containing an analyte to be measured on the ProciseDx Analyzer with specific Procise assays. The intended user for collection of the specimen is a patient, nurse or laboratory technician collecting a stool specimen. The intended user for the preparation of specimen for analysis using the ProciseDx System is a clinical laboratory, point-of-care, or physician’s office professional.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).