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    <tradeName>00884883011298</tradeName>
    <deviceName>QMS Topiramate Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:15.875Z</lastUpdated>
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    <basicUdiDi>B-00884883011281</basicUdiDi>
    <tradeName>00884883011281</tradeName>
    <deviceName>QMS Gentamicin Immunoassay (Calibrator)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:14.272Z</lastUpdated>
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    <udiDi>00884883011274</udiDi>
    <basicUdiDi>B-00884883011274</basicUdiDi>
    <tradeName>00884883011274</tradeName>
    <deviceName>QMS Lamotrigine Immunoassay (Control)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>LAMOTRIGINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:13.464Z</lastUpdated>
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    <basicUdiDi>B-00884883011267</basicUdiDi>
    <tradeName>00884883011267</tradeName>
    <deviceName>QMS Lamotrigine Immunoassay Calibrator Set</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080212</emdnCode>
    <emdnDescription>LAMOTRIGINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373787</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:11.867Z</lastUpdated>
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    <udiDi>00884883011250</udiDi>
    <basicUdiDi>B-00884883011250</basicUdiDi>
    <tradeName>00884883011250</tradeName>
    <deviceName>QMS Topiramate Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:09.466Z</lastUpdated>
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    <udiDi>00884883011243</udiDi>
    <basicUdiDi>B-00884883011243</basicUdiDi>
    <tradeName>00884883011243</tradeName>
    <deviceName>QMS Vancomycin Immunoassay Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373597</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:07.869Z</lastUpdated>
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    <udiDi>00884883011236</udiDi>
    <basicUdiDi>B-00884883011236</basicUdiDi>
    <tradeName>00884883011236</tradeName>
    <deviceName>QMS Zonisamide Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373381</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:07.067Z</lastUpdated>
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    <udiDi>00884883011229</udiDi>
    <basicUdiDi>B-00884883011229</basicUdiDi>
    <tradeName>00884883011229</tradeName>
    <deviceName>QMS Zonisamide Controls</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:05.462Z</lastUpdated>
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    <udiDi>00884883011205</udiDi>
    <basicUdiDi>B-00884883011205</basicUdiDi>
    <tradeName>00884883011205</tradeName>
    <deviceName>QMS Gentamycin Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:03.064Z</lastUpdated>
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    <udiDi>00884883011199</udiDi>
    <basicUdiDi>B-00884883011199</basicUdiDi>
    <tradeName>00884883011199</tradeName>
    <deviceName>QMS Zonisamide Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373571</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:01.462Z</lastUpdated>
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    <udiDi>00884883011182</udiDi>
    <basicUdiDi>B-00884883011182</basicUdiDi>
    <tradeName>00884883011182</tradeName>
    <deviceName>QMS Vancomycin Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373589</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:00.660Z</lastUpdated>
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    <udiDi>00884883011175</udiDi>
    <basicUdiDi>B-00884883011175</basicUdiDi>
    <tradeName>00884883011175</tradeName>
    <deviceName>QMS Topiramate Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:59.063Z</lastUpdated>
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    <udiDi>00884883011168</udiDi>
    <basicUdiDi>B-00884883011168</basicUdiDi>
    <tradeName>00884883011168</tradeName>
    <deviceName>QMS Lamotrigine Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080212</emdnCode>
    <emdnDescription>LAMOTRIGINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373795</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:56.666Z</lastUpdated>
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    <udiDi>00884883008946</udiDi>
    <basicUdiDi>B-00884883008946</basicUdiDi>
    <tradeName>00884883008946</tradeName>
    <deviceName>Alinity c Tobramycin Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P9001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:19.016Z</lastUpdated>
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    <basicUdiDi>B-00884883008939</basicUdiDi>
    <tradeName>00884883008939</tradeName>
    <deviceName>Alinity c Tobramycin Reagent Kit</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P9020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:14.996Z</lastUpdated>
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    <tradeName>00884883008533</tradeName>
    <deviceName>ARCHITECT Vancomycin</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6E44-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:38.165Z</lastUpdated>
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    <basicUdiDi>B-00884883008465</basicUdiDi>
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    <deviceName>ARCHITECT Tobramycin Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7F93-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:25.358Z</lastUpdated>
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    <deviceName>ARCHITECT Tobramycin Reagent</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7F93-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:24.545Z</lastUpdated>
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    <deviceName>ARCHITECT Theophylline</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P06-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:20.546Z</lastUpdated>
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    <deviceName>ARCHITECT Phenytoin</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P08-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:14.140Z</lastUpdated>
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