<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>07613336224908</udiDi>
    <basicUdiDi>761333602953BM</basicUdiDi>
    <tradeName>IGRA TB CS Elecsys</tradeName>
    <deviceName>CalSet IGRA TB</deviceName>
    <manufacturerName>Roche Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006260</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080901</emdnCode>
    <emdnDescription>BACTERIOLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09989960190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:24.387Z</lastUpdated>
  </row>
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