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    <tradeName>Sharay aCL IgM (CLIA)</tradeName>
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    <tradeName>Sharay aCL IgG (CLIA)</tradeName>
    <deviceName>Sharay aCL IgG (CLIA)</deviceName>
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    <tradeName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <tradeName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <tradeName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <tradeName>Cardiolipin IgM ELISA</tradeName>
    <deviceName>Cardiolipin IgM ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
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    <tradeName>Cardiolipin IgG ELISA</tradeName>
    <deviceName>Cardiolipin IgG ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
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    <tradeName>Cardiolipin-Ab IgG/IgM ELISA</tradeName>
    <deviceName>Cardiolipin-Ab IgG/IgM ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
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    <basicUdiDi>B-03532672001315</basicUdiDi>
    <tradeName>Cardio-Lisa IgM</tradeName>
    <deviceName>Cardio-Lisa IgM</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
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    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>Cardio-Lisa IgG</tradeName>
    <deviceName>Cardio-Lisa IgG</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HM 001PE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>Aptiva® APS IgG Reagent</tradeName>
    <deviceName>Aptiva® APS IgG Reagent</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725100</reference>
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    <tradeName>HemosIL CL Anti-Cardiolipin IgM</tradeName>
    <deviceName>HemosIL CL Anti-Cardiolipin IgM</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <tradeName>HemosIL AcuStar Anti-Cardiolipin IgM Controls</tradeName>
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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <tradeName>HemosIL AcuStar Anti-Cardiolipin IgG Controls</tradeName>
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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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