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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <tradeName>Total PI Noncollagenous Proteins（PINP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <tradeName>Total PI Noncollagenous Proteins（PINP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <tradeName>Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <tradeName>Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <tradeName>Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Anti-Cardiolipin antibody  (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1162-3）</reference>
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    <basicUdiDi>B-06974969982889</basicUdiDi>
    <tradeName>Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1139-1）</reference>
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    <lastUpdated>2026-06-16T09:43:57.222Z</lastUpdated>
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    <tradeName>Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1139-2）</reference>
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    <tradeName>Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1140-1）</reference>
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    <tradeName>Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <tradeName>Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）</tradeName>
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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <emdnDescription></emdnDescription>
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    <tradeName>Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <tradeName>Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <tradeName>Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <tradeName>Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1158-1）</reference>
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    <tradeName>Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
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    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1158-2）</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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