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    <tradeName>C1qScreen Negative Control Serum</tradeName>
    <deviceName>C1qScreen™ C1q</deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1QS-NC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:27.543Z</lastUpdated>
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    <udiDi>10888234500407</udiDi>
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    <tradeName>Concentrated Wash</tradeName>
    <deviceName>Concentrated Wash</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:46.056Z</lastUpdated>
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    <udiDi>10888234400516</udiDi>
    <basicUdiDi>88823411W01030402C002HJS</basicUdiDi>
    <tradeName>LIFECODES Wash Buffer</tradeName>
    <deviceName>LIFECODES Wash Buffer</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:50.689Z</lastUpdated>
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    <udiDi>00812117015231</udiDi>
    <basicUdiDi>081211701LSLJ</basicUdiDi>
    <tradeName>PE Conjugated Goat Anti-Human IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS-AB2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T04:10:56.696Z</lastUpdated>
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    <udiDi>00812117015224</udiDi>
    <basicUdiDi>081211701LSLJ</basicUdiDi>
    <tradeName>LABScreen™ Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS-NC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T04:10:52.229Z</lastUpdated>
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    <udiDi>00814695025961</udiDi>
    <basicUdiDi>081211701LSLJ</basicUdiDi>
    <tradeName>LABScreen™ Single Antigen HLA Class II ExPlex - Group 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS2AEX02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:49:03.420Z</lastUpdated>
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    <udiDi>00812117017860</udiDi>
    <basicUdiDi>081211701C1Q5J</basicUdiDi>
    <tradeName>C1qScreen Class II Postive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T03:09:14.770Z</lastUpdated>
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    <basicUdiDi>081211701C1Q5J</basicUdiDi>
    <tradeName>C1qScreen Class I Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T03:09:13.619Z</lastUpdated>
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    <udiDi>00812117016658</udiDi>
    <basicUdiDi>081211701C1Q5J</basicUdiDi>
    <tradeName>C1qScreen™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T03:09:12.489Z</lastUpdated>
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