Eu Ivdr Eu Ivd Class A On The Market

MEDILYSE 5D

Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05204309174560
Basic UDI-DI Code
5204309000159PG
Reference
1416-1087
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

This reagent is used for the lysis of red blood cells, in order to measure white blood-cell populations and hemoglobin with the automated hematology analyzers URIT 5160 and URIT 5380. For in vitro diagnostic use only, by trained laboratory professionals.

CND Nomenclature Codes

Code Description
W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

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The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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