Wright

Primary DI

05404035100226

Basic UDI-DI Code

54040351HS0236B

Reference

HS023

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Cypress Diagnostics

The Cypress Diagnostics Wright stain is an in vitro diagnostic medical device intended to be used in hematology and histology for the differential staining of nuclei and cytoplasm of different cell types, mainly blood cells. The staining is performed on air dried smears of blood and bone marrow, smears of body fluids or tissue. The device is not automated. It is a qualitative staining that provides information on the physiological or pathological state of the tissue sample when the staining obtained is interpreted by a trained professional. To obtain a diagnosis, the result is utilized alongside other information such as the patient’s medical history, physical status as well as other clinical and laboratory data obtained. This reagent is intended to be used by healthcare professionals in a laboratory-based testing environment.

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