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    <tradeName>Aptiva® APS IgM Calibrators</tradeName>
    <deviceName>Aptiva® APS IgM Calibrators</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152211</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>725141</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:26:08.553Z</lastUpdated>
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    <udiDi>08430793040761</udiDi>
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    <tradeName>Aptiva® APS IgG Calibrators</tradeName>
    <deviceName>Aptiva® APS IgG Calibrators</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
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    <reference>725101</reference>
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    <tradeName>Evo Autoimmune Standard, anti-b2-GPI IgM</tradeName>
    <deviceName>Standard anti-b2-GPI IgM - Standard anti-b2-GPI IgM</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
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    <basicUdiDi>8058945153AU2000/11LL</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, AMA IgG</tradeName>
    <deviceName>Standard AMA IgG - Standard AMA IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU2000/11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:44.296Z</lastUpdated>
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    <udiDi>08058945155554</udiDi>
    <basicUdiDi>8058945153AU2000/8GNK</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, anti-tTG IgG</tradeName>
    <deviceName>Standard anti-tTG IgG - Standard anti-tTG IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>08058945155639</udiDi>
    <basicUdiDi>8058945153AU2000/12GZ8</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, anti-b2-GPI IgG</tradeName>
    <deviceName>Standard anti-b2-GPI IgG - Standard anti-b2-GPI IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>8058945153AU2000/8AN7</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, anti-tTG IgA</tradeName>
    <deviceName>Standard anti-tTG IgA - Standard anti-tTG IgA</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <tradeName>Evo Autoimmune Standard, AGA IgG</tradeName>
    <deviceName>Standard AGA IgG - Standard AGA IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:24.224Z</lastUpdated>
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    <udiDi>08058945155431</udiDi>
    <basicUdiDi>8058945153AU2000/7AN4</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, AGA IgA</tradeName>
    <deviceName>Standard AGA IgA - Standard AGA IgA</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU2000/7A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:22.633Z</lastUpdated>
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    <udiDi>08058945155394</udiDi>
    <basicUdiDi>8058945153AU2000/5DZ</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, anti-TPO IgG</tradeName>
    <deviceName>Standard anti-TPO IgG - Standard anti-TPO IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU2000/5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:21.826Z</lastUpdated>
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    <udiDi>08058945155356</udiDi>
    <basicUdiDi>8058945153AU2000/4DX</basicUdiDi>
    <tradeName>Evo Autoimmune Standard anti-Tg IgG</tradeName>
    <deviceName>Standard anti-Tg IgG - Standard anti-Tg IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:20.226Z</lastUpdated>
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    <basicUdiDi>8058945153AU2000/3MNG</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, anti-CL IgM</tradeName>
    <deviceName>Standard anti-CL IgM - Standard anti-CL IgM</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:17.036Z</lastUpdated>
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    <tradeName>Evo Autoimmune Standard, anti-CL IgG</tradeName>
    <deviceName>Standard anti-CL IgG - Standard anti-CL IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>8058945153AU2000/2DT</basicUdiDi>
    <tradeName>Evo Autoimmune Standard, anti-DNA IgG</tradeName>
    <deviceName>Standard anti-DNA IgG - Standard anti-DNA IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T09:15:14.633Z</lastUpdated>
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    <tradeName>Evo Autoimmune Standard, anti-SSA IgG</tradeName>
    <deviceName>Standard anti-SSA IgG - Standard anti-SSA IgG</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <udiDi>06975577178770</udiDi>
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    <tradeName>AutoLumo Anti-CL IgA Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA013403</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:17:26.169Z</lastUpdated>
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    <tradeName>AutoLumo Anti-CL IgM Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
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    <tradeName>AutoLumo Anti-CL IgG Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA013203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:17:23.782Z</lastUpdated>
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    <tradeName>AutoLumo Anti-CL Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA013103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:17:17.775Z</lastUpdated>
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    <tradeName>AutoLumo Anti-β2-GP1 IgM Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA012803</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:17:16.559Z</lastUpdated>
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