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    <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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    <udiDi>00884883008175</udiDi>
    <basicUdiDi>B-00884883008175</basicUdiDi>
    <tradeName>00884883008175</tradeName>
    <deviceName>Alinity c Methadone</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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P6420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:55.566Z</lastUpdated>
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    <udiDi>00884883008168</udiDi>
    <basicUdiDi>B-00884883008168</basicUdiDi>
    <tradeName>00884883008168</tradeName>
    <deviceName>ARCHITECT Methadone</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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L35-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:53.182Z</lastUpdated>
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    <udiDi>00884883008151</udiDi>
    <basicUdiDi>B-00884883008151</basicUdiDi>
    <tradeName>00884883008151</tradeName>
    <deviceName>Alinity c Cocaine</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>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:51.566Z</lastUpdated>
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    <udiDi>00884883008144</udiDi>
    <basicUdiDi>B-00884883008144</basicUdiDi>
    <tradeName>00884883008144</tradeName>
    <deviceName>ARCHITECT Cocaine 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>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L40-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:50.769Z</lastUpdated>
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    <udiDi>00884883008120</udiDi>
    <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>
    <emdnCode>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P5820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:49.171Z</lastUpdated>
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    <udiDi>00884883008083</udiDi>
    <basicUdiDi>B-00884883008083</basicUdiDi>
    <tradeName>00884883008083</tradeName>
    <deviceName>ARCHITECT Ecstasy 500 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L42-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:46.754Z</lastUpdated>
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  <row>
    <udiDi>00884883008106</udiDi>
    <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>00884883008090</udiDi>
    <basicUdiDi>B-00884883008090</basicUdiDi>
    <tradeName>00884883008090</tradeName>
    <deviceName>ARCHITECT Ecstasy 750 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L42-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:44.480Z</lastUpdated>
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  <row>
    <udiDi>00884883008076</udiDi>
    <basicUdiDi>B-00884883008076</basicUdiDi>
    <tradeName>00884883008076</tradeName>
    <deviceName>ARCHITECT Ecstasy 250 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L42-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:28.280Z</lastUpdated>
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  <row>
    <udiDi>00884883008069</udiDi>
    <basicUdiDi>B-00884883008069</basicUdiDi>
    <tradeName>00884883008069</tradeName>
    <deviceName>ARCHITECT Ecstasy 1000 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L42-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:27.479Z</lastUpdated>
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  <row>
    <udiDi>00884883008052</udiDi>
    <basicUdiDi>B-00884883008052</basicUdiDi>
    <tradeName>00884883008052</tradeName>
    <deviceName>ARCHITECT Ecstasy 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>
    <emdnCode>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L42-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:26.695Z</lastUpdated>
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  <row>
    <udiDi>00884883008045</udiDi>
    <basicUdiDi>B-00884883008045</basicUdiDi>
    <tradeName>00884883008045</tradeName>
    <deviceName>Alinity c Ecstasy Semiquant 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:25.900Z</lastUpdated>
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    <udiDi>00884883008038</udiDi>
    <basicUdiDi>B-00884883008038</basicUdiDi>
    <tradeName>00884883008038</tradeName>
    <deviceName>Alinity c Ecstasy 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:21.896Z</lastUpdated>
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    <udiDi>00884883008021</udiDi>
    <basicUdiDi>B-00884883008021</basicUdiDi>
    <tradeName>00884883008021</tradeName>
    <deviceName>Alinity c Ecstasy Qual Calibrator 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:21.095Z</lastUpdated>
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    <udiDi>00884883008014</udiDi>
    <basicUdiDi>B-00884883008014</basicUdiDi>
    <tradeName>00884883008014</tradeName>
    <deviceName>Alinity c Barbiturates</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>W0102090103</emdnCode>
    <emdnDescription>BARBITURATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:20.288Z</lastUpdated>
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    <udiDi>00884883008007</udiDi>
    <basicUdiDi>B-00884883008007</basicUdiDi>
    <tradeName>00884883008007</tradeName>
    <deviceName>Alinity c Benzodiazepines SemiQuant 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>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:19.477Z</lastUpdated>
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    <udiDi>00884883007994</udiDi>
    <basicUdiDi>B-00884883007994</basicUdiDi>
    <tradeName>00884883007994</tradeName>
    <deviceName>Alinity c Benzodiazepines 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>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:15.502Z</lastUpdated>
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    <udiDi>00884883007987</udiDi>
    <basicUdiDi>B-00884883007987</basicUdiDi>
    <tradeName>00884883007987</tradeName>
    <deviceName>Alinity c Benzodiazepines Qual 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>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:14.695Z</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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