Carbol Gentian Violet

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

Carbol Gentian Violet

UDI-DI code

05404035100172

Basic UDI-DI

54040351HS0015Z

Reference / catalog number

HS021

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 Gram PVP stains are in vitro diagnostic medical devices intended to be used for the differentiation of Gram-positive from Gram-negative 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. For in vitro diagnostic use only. For professional use only.

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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