Polychromic solution EA-50

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

Polychromic solution EA-50

UDI-DI code

05404035100202

Basic UDI-DI

54040351HS0066B

Reference / catalog number

HS009

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 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

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