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    <tradeName>ChainFor™</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <tradeName>ChainFor™</tradeName>
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    <tradeName>ASPERGILLUS GALACTOMANNAN AG VIRCLIA® MONOTEST</tradeName>
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    <manufacturerName>Vircell, S.L</manufacturerName>
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    <tradeName>PreventID® Dermatophyte</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>PreventID® Dermatophyte</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>PreventID® Dermatophyte</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <deviceName>eazyplex® Candida auris</deviceName>
    <manufacturerName>AmplexDiagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014117</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7854</reference>
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    <lastUpdated>2026-07-30T21:42:25.199Z</lastUpdated>
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    <deviceName>eazyplex® Pneumocystis jirovecii</deviceName>
    <manufacturerName>AmplexDiagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014117</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>D-ICRG-402ED</udiDi>
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    <tradeName>Cryptococcus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <tradeName>Rightsign</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette(Whole Blood/Serum/Plasma )</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
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    <deviceName>Pneumocystis jirovecii Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
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    <deviceName>Cryptococcus Nucleic Acid Detection Kit (CSF)</deviceName>
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    <deviceName>Aspergillus Nucleic Acid Detection Kit (Sputum/BALF)</deviceName>
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    <deviceName>Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)</deviceName>
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