Eu Ivdr Eu Ivd Class A On The Market 🇧🇪 Belgium

Quick Panoptic Conc. (1:10)

Cypress Diagnostics · 🇧🇪 Belgium
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05404035100110
Basic UDI-DI Code
54040351HS00569
Reference
HS005
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
Cypress Diagnostics

Additional Description

The Cypress Diagnostics kit Quick Panoptic Conc. (1:10) is an in vitro diagnostic medical device intended to be used in hematology and histology for the differential staining of nuclei and cytoplasm of different cell types, mainly blood cells. The staining is performed on air dried smears of blood and bone marrow, smears of body fluids or tissue. 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.

CND Nomenclature Codes

Code Description
W0103010302 ROMANOWSKY STAINS

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