Kühne's Methylene Blue

Primary DI

05404035100257

Basic UDI-DI Code

54040351HS00263

Reference

HS016

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Cypress Diagnostics

The Cypress Diagnostics Ziehl-Neelsen stains are in vitro diagnostic medical devices intended to be used for the differentiation of acid-fast bacteria (such as Mycobacteria and Nocardia species and the cysts of Cryptosporidium and Isospora) from non-acid-fast bacteria. The staining is performed on smears from various body fluids. 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).