Kühne's Methylene Blue

Organization name

Cypress Diagnostics

SRN

BE-MF-000000033

Manufacturer status

Active

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• CW010

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Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Trade name

Kühne's Methylene Blue

UDI-DI code

05404035100257

Basic UDI-DI

54040351HS00263

Reference / catalog number

HS016

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0104010804STAINS

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