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    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8190] QC Sets and Panels: Helix Elite™ Enterovirus (EV) Control Panel (Inactivated Swab)</reference>
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    <lastUpdated>2026-07-16T02:55:48.363Z</lastUpdated>
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    <reference>[8211] QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel</reference>
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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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    <deviceStatus>Piyasada</deviceStatus>
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    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0057N] Helix Elite™ Molecular Standards Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:47.344Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0056N] Helix Elite™ Molecular Standards Human Papillomavirus 16 (HPV 16) Cellularity Control (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:45.745Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0044N] Helix Elite™ Molecular Standards Inactivated Influenza A/B and Respiratory Syncytial Virus</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:21.710Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0043N] Helix Elite™ Molecular Standards Inactivated Influenza A (H3N2) Virus</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:20.875Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0040N] Helix Elite™ Molecular Standards Inactivated Cytomegalovirus High Control Strain AD-169</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:15.255Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0039N] Helix Elite™ Molecular Standards Inactivated Cytomegalovirus Low Control Strain AD-169</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:14.448Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0038N] Helix Elite™ Molecular Standards Inactivated Varicella Zoster Virus Strain VZ-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:13.647Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0037N] Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 2 Strain MS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:12.855Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0036N] Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 1 Strain MacIntyre</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:08.863Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0033N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 3 Strain C243</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:06.604Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0032N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 2 Strain Greer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:02.443Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0031N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 1 Strain VP1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:01.652Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0030N] Helix Elite™ Molecular Standards Inactivated Influenza B Virus Strain Hong Kong/5/72</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:00.844Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0029N] Helix Elite™ Molecular Standards Inactivated Influenza A (H1N1) Virus</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:00.041Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0028N] Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:52:56.043Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0027N] Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:52:55.234Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0026N] Helix Elite™ Molecular Standards Inactivated Adenovirus 2 Strain Adenoid 6</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:52:54.436Z</lastUpdated>
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