Türk

Primary DI

05404035100219

Basic UDI-DI Code

54040351HS01164

Reference

HS011

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Cypress Diagnostics

The Cypress Diagnostics Türk reagent is an in vitro diagnostic medical device intended to be used in hematology for the manual counting of leukocytes in venous blood with EDTA. 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 kit is intended to be used by healthcare professionals in a laboratory-based testing environment. For in vitro diagnostic use only. For professional use only.

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