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    <deviceName>GeneStream Dengue Virus Typing1,2,3,4 Controls</deviceName>
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    <deviceName>MTBC Controls</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
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    <tradeName>LIAISON® Control Mycoplasma pneumoniae IgG</tradeName>
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    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
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    <tradeName>MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls</tradeName>
    <deviceName>Dengue virus NS1 Antigen (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>NatQal HBV</tradeName>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8254] QC Sets and Panels: Helix Elite™ Blood Culture Identification Control Panel (43 Targets)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:46.356Z</lastUpdated>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
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    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8250] QC Sets and Panels: Helix Elite™ Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:44.842Z</lastUpdated>
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    <reference>[8246] QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)</reference>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8249] QC Sets and Panels: Helix Elite™ Bacterial Vaginosis (BV) Control Panel</reference>
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    <reference>[8247] QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)</reference>
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    <reference>[8235] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel</reference>
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    <reference>[8236] QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)</reference>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8206] QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:16.876Z</lastUpdated>
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