ASP Device

Primary DI

00860008222404

Basic UDI-DI Code

08600082224ASPMK

Reference

PI-0076558

Device Types

New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

ASP Health Inc.

The ASP automated sample deposition and slide stainer is a dual-purpose microprocessor-controlled cell preparation and slide staining system intended to prepare cytologic specimens for examination. The ASP System is intended for use in a professional medical facility such as a hospital or clinic and is not intended for home use. The ASP System is intended as a stationary device operated on a cart or station. The ASP System consists of a benchtop instrument which can be operated by personnel using a set of consumables – both custom and off-the-shelf. The ASP System incorporates a patented core technology in the form of a dual spray nozzle for achieving cell deposition as well as slide fixing and staining subsystems. The ASP System takes cell samples deposited by the operator from a needle, pipette, or custom container into a port on a custom consumable. The ASP System sprays the sample onto two slides, one slide is optionally wet-fixed and the other stained using Romanowsky stains.

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