Giemsa

Primary DI

05404035100127

Basic UDI-DI Code

54040351HS00365

Reference

HS003

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Cypress Diagnostics

The Cypress Diagnostics Giemsa and May-Grünwald stains are in vitro diagnostic medical devices intended to be used 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 devices are 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.

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).