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    <tradeName>LIAISON® MUREX Control Anti-HEV IgG</tradeName>
    <deviceName>LIAISON® MUREX Control Anti-HEV IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311271</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:43.405Z</lastUpdated>
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    <udiDi>08056771103299</udiDi>
    <basicUdiDi>B-08056771103299</basicUdiDi>
    <tradeName>LIAISON® Control QuantiFERON®-TB Gold Plus</tradeName>
    <deviceName>LIAISON® Control QuantiFERON®-TB Gold Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T22:39:37.007Z</lastUpdated>
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    <udiDi>08056771101172</udiDi>
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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>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <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>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>317001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <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>
    <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>310861</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:25.025Z</lastUpdated>
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    <udiDi>08056771100960</udiDi>
    <basicUdiDi>805677131079658</basicUdiDi>
    <tradeName>LIAISON® XL Control Toxo IgG Avidity</tradeName>
    <deviceName>LIAISON® XL Control Toxo IgG Avidity</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>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310796</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:24.200Z</lastUpdated>
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    <udiDi>08056771100946</udiDi>
    <basicUdiDi>80567713107814T</basicUdiDi>
    <tradeName>LIAISON® Control Toxo IgG II</tradeName>
    <deviceName>LIAISON® Control Toxo IgG II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310781</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:19.423Z</lastUpdated>
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    <udiDi>08056771100922</udiDi>
    <basicUdiDi>80567713107664X</basicUdiDi>
    <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>
    <legislation>IVDR 2017/746</legislation>
    <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>00630414989907</udiDi>
    <basicUdiDi>0405686901428VL</basicUdiDi>
    <tradeName>IMMULITE H. pylori IgG Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_H. pylori IgG Control Module</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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10469596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:59.718Z</lastUpdated>
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    <udiDi>00850075956241</udiDi>
    <basicUdiDi>0816784020119Y3</basicUdiDi>
    <tradeName>Optitrol NAT HPV neg, 5x 1.2 mL</tradeName>
    <deviceName>Optitrol NAT HPV neg, 5x 1.2 mL</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT06013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:28.770Z</lastUpdated>
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    <udiDi>00850075956227</udiDi>
    <basicUdiDi>0816784020118XZ</basicUdiDi>
    <tradeName>Optitrol NAT HPV, 5x 1.2 mL</tradeName>
    <deviceName>Optitrol NAT HPV, 5x 1.2 mL</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT06011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:27.969Z</lastUpdated>
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    <udiDi>00850075956050</udiDi>
    <basicUdiDi>0816784020117XX</basicUdiDi>
    <tradeName>Optitrol NAT HAV, 10x 1.2 mL</tradeName>
    <deviceName>Optitrol NAT HAV, 5x 1.2 mL</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT05012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:27.169Z</lastUpdated>
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    <udiDi>00850075956036</udiDi>
    <basicUdiDi>0816784020115XT</basicUdiDi>
    <tradeName>Optitrol NAT CT/NG, 5x 1.2 mL</tradeName>
    <deviceName>Optitrol NAT CT/NG, 5x 1.2 mL</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT02011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:23.167Z</lastUpdated>
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    <udiDi>00850075956012</udiDi>
    <basicUdiDi>0816784020116XV</basicUdiDi>
    <tradeName>Optitrol NAT CMV, 5x 1.2 mL</tradeName>
    <deviceName>Optitrol NAT CMV, 5x 1.2 mL</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT02021</reference>
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    <lastUpdated>2026-07-22T03:42:22.370Z</lastUpdated>
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    <udiDi>00850075956043</udiDi>
    <basicUdiDi>0816784020115XT</basicUdiDi>
    <tradeName>Optitrol NAT CT/NG, 10x 1.2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T03:36:40.310Z</lastUpdated>
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    <udiDi>00850075956029</udiDi>
    <basicUdiDi>0816784020116XV</basicUdiDi>
    <tradeName>Optitrol NAT CMV, 10x 1.2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T03:36:38.109Z</lastUpdated>
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    <udiDi>00850075956753</udiDi>
    <basicUdiDi>0816784020117XX</basicUdiDi>
    <tradeName>Optitrol NAT HAV, 5x 1.2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT05011</reference>
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    <lastUpdated>2026-07-22T03:36:38.059Z</lastUpdated>
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    <basicUdiDi>0816784020118XZ</basicUdiDi>
    <tradeName>Optitrol NAT HPV, 10x 1.2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT06012</reference>
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    <lastUpdated>2026-07-22T03:36:37.602Z</lastUpdated>
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    <basicUdiDi>0816784020119Y3</basicUdiDi>
    <tradeName>Optitrol NAT HPV neg, 10x 1.2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT06014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:33.067Z</lastUpdated>
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