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    <tradeName>Anti-Sm Antibody IgG CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <tradeName>ANA  Screening Antibody CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <tradeName>AutoLumo Anti-dsDNA IgG Calibrators</tradeName>
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    <tradeName>AutoLumo ANA IgG Calibrators</tradeName>
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    <tradeName>MosaiQ® AiPlex CTDplus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160005</reference>
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    <tradeName>MosaiQ® AiPlex CTDplus</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>803389132CHORUSSSA00BW</basicUdiDi>
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    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-06-16T04:52:06.815Z</lastUpdated>
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    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>CHORUS dsDNA-M</tradeName>
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    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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