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    <tradeName>LinkSēq HLA-Single Locus ACDRDQDP 384 Typing Kit</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></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.236Z</lastUpdated>
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    <tradeName>LinkSēq HLA-B 384 Typing Kit</tradeName>
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    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
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    <tradeName>LinkSēq HLA-B 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <tradeName>LinkSēq HLA-ABDR 384 Typing Kit</tradeName>
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    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3331C</reference>
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    <tradeName>LinkSēq HLA-ABDR 384 Typing Kit</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></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3332C</reference>
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    <lastUpdated>2026-06-16T20:37:32.139Z</lastUpdated>
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    <udiDi>00814695025602</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-B27 Typing Kit</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></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8011C-SL</reference>
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    <tradeName>LinkSēq HLA-B27 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>LinkSēq HLA-B*57:01 Typing Kit</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></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T20:37:32.028Z</lastUpdated>
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    <tradeName>LinkSēq HLA-B*57:01 Typing Kit</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></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8020C-SR</reference>
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    <lastUpdated>2026-06-16T20:37:32.001Z</lastUpdated>
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    <tradeName>LABType™ SSO Typing Test</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>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:38.672Z</lastUpdated>
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    <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>UNKNOWN</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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    <tradeName>C1qScreen Class I Positive Control</tradeName>
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    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T03:09:13.619Z</lastUpdated>
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    <tradeName>C1qScreen™</tradeName>
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    <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>
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    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T03:09:12.489Z</lastUpdated>
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    <tradeName>C1qScreen Negative Control Serum</tradeName>
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    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T03:09:11.334Z</lastUpdated>
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