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    <tradeName>LIAISON® Biotrin Control Parvovirus B19 IgM</tradeName>
    <deviceName>LIAISON® Biotrin Control Parvovirus B19 IgM</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>317011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:29.053Z</lastUpdated>
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    <udiDi>08056771101158</udiDi>
    <basicUdiDi>B-08056771101158</basicUdiDi>
    <tradeName>LIAISON® Biotrin Control Parvovirus B19 IgG</tradeName>
    <deviceName>LIAISON® Biotrin Control Parvovirus B19 IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
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    <lastUpdated>2026-07-22T22:39:27.463Z</lastUpdated>
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    <udiDi>08056771101080</udiDi>
    <basicUdiDi>80567713108614S</basicUdiDi>
    <tradeName>LIAISON® Control VZV IgM</tradeName>
    <deviceName>LIAISON® Control VZV IgM</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>08056771100922</udiDi>
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    <tradeName>LIAISON® Control CMV IgG Avidity II</tradeName>
    <deviceName>LIAISON® Control CMV IgG Avidity II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310766</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:15.432Z</lastUpdated>
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    <udiDi>08056771100854</udiDi>
    <basicUdiDi>80567713107314C</basicUdiDi>
    <tradeName>LIAISON® Control Rubella IgM</tradeName>
    <deviceName>LIAISON® Control Rubella IgM</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310731</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:14.193Z</lastUpdated>
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    <udiDi>00842768022838</udiDi>
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    <tradeName>Atellica IM Herpes-2 IgG Quality Control (HSV2 QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:52:25.517Z</lastUpdated>
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    <basicUdiDi>0405686901855WB</basicUdiDi>
    <tradeName>Atellica IM Herpes-1 IgG Quality Control (HSV1 QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:52:23.918Z</lastUpdated>
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    <udiDi>00630414976709</udiDi>
    <basicUdiDi>0405686901475VV</basicUdiDi>
    <tradeName>IMMULITE CMV IgG Control</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_CMV IgG Controls</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10469595</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:09.112Z</lastUpdated>
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    <udiDi>00630414016757</udiDi>
    <basicUdiDi>0405686901855WB</basicUdiDi>
    <tradeName>ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720847</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:11.307Z</lastUpdated>
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    <udiDi>00630414016733</udiDi>
    <basicUdiDi>0405686901856WD</basicUdiDi>
    <tradeName>ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720850</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:09.705Z</lastUpdated>
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    <udiDi>08054320950158</udiDi>
    <basicUdiDi>805432095ISID5330MC</basicUdiDi>
    <tradeName>08054320950158</tradeName>
    <deviceName>IDS Rubella Avidity Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5330</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:24.484Z</lastUpdated>
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    <udiDi>08054320950134</udiDi>
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    <tradeName>08054320950134</tradeName>
    <deviceName>IDS CMV Avidity Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5530</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:20.242Z</lastUpdated>
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    <tradeName>08054320950127</tradeName>
    <deviceName>IDS CMV Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5430</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:19.031Z</lastUpdated>
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    <deviceName>IDS Rubella Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>ADVIA Centaur Rub M quality control material</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <reference>10310286</reference>
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    <lastUpdated>2026-07-17T02:14:08.654Z</lastUpdated>
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    <tradeName>MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls</tradeName>
    <deviceName>Dengue virus NS1 Antigen (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201401MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:56.412Z</lastUpdated>
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    <tradeName>70845357043602</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
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    <reference>[8246] QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:42.043Z</lastUpdated>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8235] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:21.988Z</lastUpdated>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
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    <reference>[8234] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)</reference>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8205] QC Sets and Panels: Helix Elite™ Norovirus Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:55.564Z</lastUpdated>
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