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Terviseamet

Medical device

MSA code 16716
UDI code
Seadme klass In vitro diagnostikaseade (IVD meditsiiniseade)
Risk class IVD
Appliance -
Device name (in Estonian) AB Seerum kvantifitseerimiseks
Device name (in English) AB Serum for Quantification
Intended use (is Estonian) Professionaalseks kasutamiseks IVD-aparaadina rakukokteili koostisosana, mida kasutatakse anti-D ja anti-c antikehade kvantifitseerimiseks.
Intended use (in English) For professional use as an IVD device as a constituent of the cell cocktail used for quantification of anti-D and anti-c antibodies.
Type/model/article number PN062
Manufacturer NHS Blood and Transplant
Authorized spokesman Quality First International OÜ
In register from 06/10/2021
Status Active
EHK soodustus EHK soodustus puudub
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