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    <deviceName>ARCHITECT Digoxin 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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E06-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:57.987Z</lastUpdated>
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    <basicUdiDi>B-00884883008182</basicUdiDi>
    <tradeName>00884883008182</tradeName>
    <deviceName>ARCHITECT Digoxin 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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E06-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:57.162Z</lastUpdated>
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    <basicUdiDi>B-00884883008120</basicUdiDi>
    <tradeName>00884883008120</tradeName>
    <deviceName>Alinity c Carbamazepine 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>
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    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P5820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:49.171Z</lastUpdated>
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    <basicUdiDi>B-00884883008106</basicUdiDi>
    <tradeName>00884883008106</tradeName>
    <deviceName>ARCHITECT Phenobarbital</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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P07-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:45.162Z</lastUpdated>
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    <udiDi>00884883007970</udiDi>
    <basicUdiDi>B-00884883007970</basicUdiDi>
    <tradeName>00884883007970</tradeName>
    <deviceName>ARCHITECT Carbamazepine</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P05-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:13.892Z</lastUpdated>
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    <udiDi>00884883007901</udiDi>
    <basicUdiDi>B-00884883007901</basicUdiDi>
    <tradeName>00884883007901</tradeName>
    <deviceName>08P5520</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>08P5520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:01.871Z</lastUpdated>
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    <udiDi>00884883007895</udiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <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>00884883007833</udiDi>
    <basicUdiDi>B-00884883007833</basicUdiDi>
    <tradeName>00884883007833</tradeName>
    <deviceName>ARCHITECT Valproic Acid</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>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E13-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:53.863Z</lastUpdated>
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    <udiDi>00884883007451</udiDi>
    <basicUdiDi>B-00884883007451</basicUdiDi>
    <tradeName>00884883007451</tradeName>
    <deviceName>ARCHITECT Amikacin</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>6L35-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:48.261Z</lastUpdated>
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    <udiDi>00884883007123</udiDi>
    <basicUdiDi>B-00884883007123</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08772525190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:23.402Z</lastUpdated>
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    <udiDi>00884883006072</udiDi>
    <basicUdiDi>B-00884883006072</basicUdiDi>
    <tradeName>00884883006072</tradeName>
    <deviceName>QMS Lidocaine 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>W0102080105</emdnCode>
    <emdnDescription>LIDOCAINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374686</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:49.777Z</lastUpdated>
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    <udiDi>00884883006003</udiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080109</emdnCode>
    <emdnDescription>QUINIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:44.962Z</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>00884883005686</udiDi>
    <basicUdiDi>B-00884883005686</basicUdiDi>
    <tradeName>00884883005686</tradeName>
    <deviceName>QMS Amikacin Immunossay 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>W0102080301</emdnCode>
    <emdnDescription>AMIKACIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374157</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:59.299Z</lastUpdated>
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    <udiDi>00884883005648</udiDi>
    <basicUdiDi>B-00884883005648</basicUdiDi>
    <tradeName>00884883005648</tradeName>
    <deviceName>CEDIA Digitoxin Assay</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>W0102080102</emdnCode>
    <emdnDescription>DIGITOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:52.904Z</lastUpdated>
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    <basicUdiDi>B-00884883005631</basicUdiDi>
    <tradeName>00884883005631</tradeName>
    <deviceName>CEDIA Tobramycin II</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>100018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:52.094Z</lastUpdated>
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    <basicUdiDi>B-00884883005624</basicUdiDi>
    <tradeName>00884883005624</tradeName>
    <deviceName>CEDIA Procainamide Assay</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>W0102080107</emdnCode>
    <emdnDescription>PROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:48.099Z</lastUpdated>
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    <deviceName>CEDIA N-Acetylprocainamide Assay (NAPA)</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>W0102080106</emdnCode>
    <emdnDescription>N-ACETYLPROCAINAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:45.701Z</lastUpdated>
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    <basicUdiDi>B-00884883004597</basicUdiDi>
    <tradeName>00884883004597</tradeName>
    <deviceName>QMS Everolimus 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>
    <emdnCode>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373878</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:20:19.054Z</lastUpdated>
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