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    <tradeName>+ENTIEBVG01500V</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (VCA) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <reference>EBVG0150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:29.979Z</lastUpdated>
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    <udiDi>+ENTIAEBV71500W</udiDi>
    <basicUdiDi>B-+ENTIAEBV71500W</basicUdiDi>
    <tradeName>+ENTIAEBV71500W</tradeName>
    <deviceName>NovaLisa® Avidity Epstein-Barr Virus (VCA) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBV7150</reference>
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    <lastUpdated>2026-07-16T10:08:40.232Z</lastUpdated>
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    <udiDi>+ENTI302193000E</udiDi>
    <basicUdiDi>B-+ENTI302193000E</basicUdiDi>
    <tradeName>+ENTI302193000E</tradeName>
    <deviceName>Epstein-Barr Virus (EA-D) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30219300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:25.392Z</lastUpdated>
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    <udiDi>+ENTI301136240G</udiDi>
    <basicUdiDi>B-+ENTI301136240G</basicUdiDi>
    <tradeName>+ENTI301136240G</tradeName>
    <deviceName>Epstein-Barr Virus (VCA) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:56.712Z</lastUpdated>
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    <udiDi>08056771100700</udiDi>
    <basicUdiDi>805677131054043</basicUdiDi>
    <tradeName>LIAISON® EA IgG</tradeName>
    <deviceName>LIAISON® EA IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310540</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:07:56.807Z</lastUpdated>
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    <udiDi>08056771100687</udiDi>
    <basicUdiDi>80567713105203V</basicUdiDi>
    <tradeName>LIAISON® EBNA IgG</tradeName>
    <deviceName>LIAISON® EBNA IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310520</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:07:55.704Z</lastUpdated>
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    <udiDi>08056771100663</udiDi>
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    <tradeName>LIAISON® VCA IgG</tradeName>
    <deviceName>LIAISON® VCA IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:07:54.908Z</lastUpdated>
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    <udiDi>08056771100649</udiDi>
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    <tradeName>LIAISON ® EBV IgM</tradeName>
    <deviceName>LIAISON® EBV IgM</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>EBV IGM - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:07:54.103Z</lastUpdated>
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    <udiDi>00630414999845</udiDi>
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    <tradeName>IMMULITE 2000 EBV-VCA IgM</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgM</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10488005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:35.223Z</lastUpdated>
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    <udiDi>00630414999876</udiDi>
    <basicUdiDi>0405686900225UV</basicUdiDi>
    <tradeName>IMMULITE 2000 EBV-VCA IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:43.055Z</lastUpdated>
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    <udiDi>00630414999838</udiDi>
    <basicUdiDi>0405686900224UT</basicUdiDi>
    <tradeName>IMMULITE 2000 EBV-EBNA IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_EBV-EBNA IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:40.272Z</lastUpdated>
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    <udiDi>D-KR-EBV-02100CUL</udiDi>
    <basicUdiDi>B-KR-EBV-02100CUL</basicUdiDi>
    <tradeName>INNODX EBV VCA IgA CMIA</tradeName>
    <deviceName>INNODX EBV VCA IgA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-EBV-02100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:47.224Z</lastUpdated>
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    <udiDi>D-KR-EBV-01100CU9</udiDi>
    <basicUdiDi>B-KR-EBV-01100CU9</basicUdiDi>
    <tradeName>INNODX EBV EBNA1 IgA CMIA</tradeName>
    <deviceName>INNODX EBV EBNA1 IgA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-EBV-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:46.417Z</lastUpdated>
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    <udiDi>D-IENG-R4027C</udiDi>
    <basicUdiDi>B-IENG-R4027C</basicUdiDi>
    <tradeName>EBNA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBNA IgG Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IENG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:13.980Z</lastUpdated>
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    <udiDi>D-IECNG-R4255A</udiDi>
    <basicUdiDi>B-IECNG-R4255A</basicUdiDi>
    <tradeName>EBV VCA and EBNA IgG Combo Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA and EBNA IgG Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECNG-R425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:34.626Z</lastUpdated>
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    <udiDi>D-IECG-R402ZE</udiDi>
    <basicUdiDi>B-IECG-R402ZE</basicUdiDi>
    <tradeName>EBV VCA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA IgG Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:33.818Z</lastUpdated>
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    <udiDi>48594036040845</udiDi>
    <basicUdiDi>B-48594036040845</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-VCA EBV IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-084/5ST</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:09:49.522Z</lastUpdated>
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    <basicUdiDi>B-38594036041203</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-EA (D) EBV IgG</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-120-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:53:51.718Z</lastUpdated>
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    <tradeName>MONO-VIDITEST anti-EA (D) EBV IgM</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>EBV EA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:53:50.913Z</lastUpdated>
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    <basicUdiDi>B-38594036041111</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-EBNA-1 EBV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-111-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:53:35.665Z</lastUpdated>
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