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    <tradeName>Emit 2000 Gentamicin Plus Assay</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <tradeName>Emit® 2000 Gentamicin Plus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <tradeName>Gentamicin Reagent (GEN 2 x 100)</tradeName>
    <deviceName>Gentamicin Reagent (GEN 2 x 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <tradeName>07613336190807</tradeName>
    <deviceName>CEDIA Gentamicin II Assay (100 tests)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09026924190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:04.625Z</lastUpdated>
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    <basicUdiDi>B-07613336190753</basicUdiDi>
    <tradeName>07613336190753</tradeName>
    <deviceName>CEDIA Gentamicin II Assay (125 tests)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09086137190</reference>
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    <tradeName>00884883012677</tradeName>
    <deviceName>QMS Gentamicin Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T09:32:09.643Z</lastUpdated>
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    <deviceName>QMS Gentamicin Immunoassay (Calibrator)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T09:30:14.272Z</lastUpdated>
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    <deviceName>QMS Gentamycin Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <tradeName>00884883007901</tradeName>
    <deviceName>08P5520</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:01.871Z</lastUpdated>
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    <basicUdiDi>B-00884883007895</basicUdiDi>
    <tradeName>00884883007895</tradeName>
    <deviceName>ARCHITECT Gentamicin</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E11-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:01.089Z</lastUpdated>
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    <udiDi>00884883007123</udiDi>
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    <tradeName>00884883007123</tradeName>
    <deviceName>CEDIA Gentamicin II Assay (95 tests)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08772525190</reference>
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    <lastUpdated>2026-07-05T09:24:23.402Z</lastUpdated>
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    <udiDi>00884883001312</udiDi>
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    <tradeName>00884883001312</tradeName>
    <deviceName>CEDIA Gentamicin II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:18.565Z</lastUpdated>
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    <udiDi>06942293590605</udiDi>
    <basicUdiDi>697518250F11411ZW</basicUdiDi>
    <tradeName>Gentamicin CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Gentamicin CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11411</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:42.855Z</lastUpdated>
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