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    <tradeName>Lipoprotein (a) Molarity Assay Control Set</tradeName>
    <deviceName>Lipoprotein (a) Molarity Assay Control Set</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DZ098A-CON</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T18:52:35.846Z</lastUpdated>
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    <tradeName>Lipoprotein (a) Molarity Assay Calibrator Set</tradeName>
    <deviceName>Lipoprotein (a) Molarity Assay Calibrator Set</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
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    <tradeName>Lipoprotein (a) Molarity Assay</tradeName>
    <deviceName>Lipoprotein (a) Molarity Assay; Lipoprotein (a) Molarity PCh Assay</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
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    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
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    <lastUpdated>2026-08-11T18:52:31.845Z</lastUpdated>
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    <tradeName>β-Hydroxybutyrate (BHB) Calibrator Kit</tradeName>
    <deviceName>β-Hydroxybutyrate Calibrator Kit</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DZ153A-CAL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T18:52:31.051Z</lastUpdated>
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    <basicUdiDi>0817089023154XB</basicUdiDi>
    <tradeName>β-Hydroxybutyrate (BHB) Control Kit</tradeName>
    <deviceName>β-Hydroxybutyrate Control Set</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DZ153A-CON</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T18:52:30.307Z</lastUpdated>
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    <basicUdiDi>0817089023147XE</basicUdiDi>
    <tradeName>β-Hydroxybutyrate (BHB) Assay</tradeName>
    <deviceName>β-Hydroxybutyrate Assay</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DZ153A-KY1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T18:52:29.451Z</lastUpdated>
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    <basicUdiDi>0817089024311XA</basicUdiDi>
    <tradeName>Lipoprotein (a) Molarity Assay</tradeName>
    <deviceName>Lipoprotein (a) Molarity Assay; Lipoprotein (a) Molarity PCh Assay</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DZ098A-BY1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:17:50.809Z</lastUpdated>
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    <tradeName>β-Hydroxybutyrate Calibrator Kit</tradeName>
    <deviceName>β-Hydroxybutyrate Calibrator Kit</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10581964190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:17:48.399Z</lastUpdated>
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    <basicUdiDi>0817089023147XE</basicUdiDi>
    <tradeName>β-Hydroxybutyrate Assay</tradeName>
    <deviceName>β-Hydroxybutyrate Assay</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10581948190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:17:47.612Z</lastUpdated>
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    <udiDi>00817089023833</udiDi>
    <basicUdiDi>0817089023154XB</basicUdiDi>
    <tradeName>β-Hydroxybutyrate Control Set</tradeName>
    <deviceName>β-Hydroxybutyrate Control Set</deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10582014190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:17:45.991Z</lastUpdated>
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    <basicUdiDi>0817089024311XA</basicUdiDi>
    <tradeName>LPAPM Lipoprotein (a) Molarity PCh Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:58.602Z</lastUpdated>
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    <basicUdiDi>0817089024311XA</basicUdiDi>
    <tradeName>LPAPM Lipoprotein (a) Molarity PCh Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>0817089024311XA</basicUdiDi>
    <tradeName>LPAPM Lipoprotein (a) Molarity PCh Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diazyme Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025166</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10792540190</reference>
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    <lastUpdated>2026-08-10T19:49:57.763Z</lastUpdated>
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