Harris' Hematoxylin

Primary DI

05404035100189

Basic UDI-DI Code

54040351HS0066B

Reference

HS006

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Cypress Diagnostics

The Cypress Diagnostics Papanicolaou's Stains are in vitro diagnostic medical devices intended to be used in histocytology for the nuclear and cytoplasmic staining of cells. The staining is performed on cytological and histological samples from different origin. 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.

The Basic UDI-DI associated with this device has 3 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).