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    <deviceName>Acrometrix BKV High Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:55.369Z</lastUpdated>
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    <basicUdiDi>B-00884883006393</basicUdiDi>
    <tradeName>00884883006393</tradeName>
    <deviceName>Acrometrix BKV Low Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
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    <lastUpdated>2026-07-05T09:23:53.792Z</lastUpdated>
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    <basicUdiDi>B-00884883006362</basicUdiDi>
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    <deviceName>Urine Dipstick Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
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    <lastUpdated>2026-07-05T09:23:51.370Z</lastUpdated>
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    <basicUdiDi>B-00884883006072</basicUdiDi>
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    <deviceName>QMS Lidocaine Immunoassay</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>LIDOCAINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374686</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:49.777Z</lastUpdated>
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    <basicUdiDi>B-00884883006065</basicUdiDi>
    <tradeName>00884883006065</tradeName>
    <deviceName>CEDIA Bupernorphine II 0ng/mL Calibrator</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>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10021390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:48.977Z</lastUpdated>
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    <tradeName>00884883006058</tradeName>
    <deviceName>CEDIA Bupernorphine II 20ng/mL Calibrator</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>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:47.367Z</lastUpdated>
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    <basicUdiDi>B-00884883006003</basicUdiDi>
    <tradeName>00884883006003</tradeName>
    <deviceName>QMS Quinidine Calibrators</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>
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    <emdnDescription>QUINIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:44.962Z</lastUpdated>
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    <basicUdiDi>B-00884883006041</basicUdiDi>
    <tradeName>00884883006041</tradeName>
    <deviceName>CEDIA Bupernorphine II 50ng/mL Calibrator</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>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10020801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:43.365Z</lastUpdated>
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    <tradeName>00884883006034</tradeName>
    <deviceName>CEDIA Bupernorphine II 100ng/mL 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>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10020802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:42.676Z</lastUpdated>
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    <udiDi>00884883005990</udiDi>
    <basicUdiDi>B-00884883005990</basicUdiDi>
    <tradeName>00884883005990</tradeName>
    <deviceName>QMS Quinidine 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>W0102080109</emdnCode>
    <emdnDescription>QUINIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373936</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:26.516Z</lastUpdated>
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    <udiDi>00884883005983</udiDi>
    <basicUdiDi>B-00884883005983</basicUdiDi>
    <tradeName>00884883005983</tradeName>
    <deviceName>QMS Amikacin 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>W0102080301</emdnCode>
    <emdnDescription>AMIKACIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373910</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:25.712Z</lastUpdated>
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    <udiDi>00884883005976</udiDi>
    <basicUdiDi>B-00884883005976</basicUdiDi>
    <tradeName>00884883005976</tradeName>
    <deviceName>Acrometrix  WNVRNA (10 x 1.4 mL)</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>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>960500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:24.903Z</lastUpdated>
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    <basicUdiDi>B-00884883005969</basicUdiDi>
    <tradeName>00884883005969</tradeName>
    <deviceName>DRI Negative Urine 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1388</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:24.107Z</lastUpdated>
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    <basicUdiDi>B-00884883005952</basicUdiDi>
    <tradeName>00884883005952</tradeName>
    <deviceName>DRI Oxycodone Calibrator 500</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>
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    <emdnCode>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:20.127Z</lastUpdated>
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    <basicUdiDi>B-00884883005914</basicUdiDi>
    <tradeName>00884883005914</tradeName>
    <deviceName>CEDIA Multi-Drug Optional Cutoff Calibrator</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>100033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:19.317Z</lastUpdated>
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    <basicUdiDi>B-00884883005907</basicUdiDi>
    <tradeName>00884883005907</tradeName>
    <deviceName>AcroMetrix BB NAT WNV Negative Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>960600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:18.510Z</lastUpdated>
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    <deviceName>DRI Oxycodone Calibrator 100</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:17.720Z</lastUpdated>
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    <deviceName>Hema-Trol</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYC84669</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:13.700Z</lastUpdated>
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    <deviceName>Hema-Trol</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
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    <reference>HYC84668</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <deviceName>Hema-Trol</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYC84667</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:12.101Z</lastUpdated>
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