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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <tradeName>VALIDATE® CM1 Test Set</tradeName>
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    <tradeName>VALIDATE® CM1 Test Set</tradeName>
    <deviceName>VALIDATE® CM1 Test Set</deviceName>
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    <tradeName>VALIDATE® HS Troponin Test Set</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <tradeName>VALIDATE® CM1 Test Set</tradeName>
    <deviceName>VALIDATE® CM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <tradeName>VALIDATE® CM3 Test Set</tradeName>
    <deviceName>VALIDATE® CM3 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
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    <tradeName>MAGLUMI hs-CRP (CLIA) Controls</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>MAGLUMI H-FABP (CLIA) Controls</tradeName>
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    <lastUpdated>2026-07-02T07:51:09.491Z</lastUpdated>
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    <tradeName>TROPONIN T CONTROL (TROPONIN T CONTROL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ10462</reference>
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    <lastUpdated>2026-07-01T22:42:01.150Z</lastUpdated>
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    <tradeName>Access BNP QC</tradeName>
    <deviceName>Access BNP QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-01T08:40:04.705Z</lastUpdated>
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    <tradeName>Pylon Cardiac Control 2</tradeName>
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    <manufacturerName>ET Healthcare (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039448</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <tradeName>Cardiac Markers Control</tradeName>
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    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
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