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    <basicUdiDi>B-00859110005036</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301db</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:13.486Z</lastUpdated>
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    <udiDi>00859110005012</udiDi>
    <basicUdiDi>B-00859110005012</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301au</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:12.788Z</lastUpdated>
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    <udiDi>00859110005005</udiDi>
    <basicUdiDi>B-00859110005005</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301ab</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:07.894Z</lastUpdated>
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    <udiDi>00858724003353</udiDi>
    <basicUdiDi>B-00858724003353</basicUdiDi>
    <tradeName>ARK Lacosamide Control</tradeName>
    <deviceName>ARK Lacosamide Control</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5033-0003-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:06.290Z</lastUpdated>
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    <udiDi>00858724003247</udiDi>
    <basicUdiDi>B-00858724003247</basicUdiDi>
    <tradeName>ARK Voriconazole II Control</tradeName>
    <deviceName>ARK Voriconazole II Control</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5030-0003-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:00.685Z</lastUpdated>
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    <udiDi>00858724003124</udiDi>
    <basicUdiDi>B-00858724003124</basicUdiDi>
    <tradeName>ARK Topiramate Control</tradeName>
    <deviceName>ARK Topiramate Control</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5015-0003-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:54.272Z</lastUpdated>
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    <udiDi>00850011135396</udiDi>
    <basicUdiDi>B-00850011135396</basicUdiDi>
    <tradeName>VALIDATE® Immunosuppressants</tradeName>
    <deviceName>VALIDATE® Immunosuppressants</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>608mm</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:47.732Z</lastUpdated>
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    <udiDi>00380740101220</udiDi>
    <basicUdiDi>B-00380740101220</basicUdiDi>
    <tradeName>00380740101220</tradeName>
    <deviceName>TDM Multiconstituent Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P04-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:01.964Z</lastUpdated>
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    <udiDi>06947145586171</udiDi>
    <basicUdiDi>694714551046J4</basicUdiDi>
    <tradeName>MAGLUMI Cyclosporine (CLIA) Controls</tradeName>
    <deviceName>Cyclosporine (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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011046MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:54:04.953Z</lastUpdated>
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    <udiDi>06947145580605</udiDi>
    <basicUdiDi>69471455485WV</basicUdiDi>
    <tradeName>MAGLUMI Tacrolimus (CLIA) Controls</tradeName>
    <deviceName>Tacrolimus (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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011036MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:56.142Z</lastUpdated>
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    <udiDi>03532672001537</udiDi>
    <basicUdiDi>353267CTI003TPCA65</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTI 003T-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:08.227Z</lastUpdated>
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    <udiDi>03532672001520</udiDi>
    <basicUdiDi>353267CTA003TPCAZA</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTA 003T-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:06.629Z</lastUpdated>
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    <udiDi>03532672000479</udiDi>
    <basicUdiDi>353267CTO003PCAX5</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Ocrelizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTO 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:05.829Z</lastUpdated>
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    <udiDi>03532672000462</udiDi>
    <basicUdiDi>353267CTO002PCAWW</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Ocrelizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTO 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:04.228Z</lastUpdated>
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    <udiDi>03532672000431</udiDi>
    <basicUdiDi>353267CTRZ003PCAR8</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Risankizumab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTRZ 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:01.831Z</lastUpdated>
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    <udiDi>03532672000424</udiDi>
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    <tradeName>IMMUNO-TROL i-Tracker Risankizumab</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTRZ 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:00.236Z</lastUpdated>
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    <basicUdiDi>353267CTE003PCART</basicUdiDi>
    <tradeName>IMMUNO-TROL i-Tracker Anti-Etanercept</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
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    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTE 003-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:59.428Z</lastUpdated>
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    <tradeName>IMMUNO-TROL i-Tracker Etanercept</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
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    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTE 002-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:25:57.833Z</lastUpdated>
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    <udiDi>00630414615509</udiDi>
    <basicUdiDi>0405686902180VE</basicUdiDi>
    <tradeName>N aTNFa Controls ETA</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873744</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:56.690Z</lastUpdated>
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    <tradeName>N aTNFa Controls INF</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
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    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873742</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:56.599Z</lastUpdated>
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