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    <deviceName>CEDIA Buprenorphine 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>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:28.484Z</lastUpdated>
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    <basicUdiDi>B-00884883001749</basicUdiDi>
    <tradeName>00884883001749</tradeName>
    <deviceName>CEDIA Buprenorphine 75 ng/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>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:27.439Z</lastUpdated>
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    <udiDi>00884883001732</udiDi>
    <basicUdiDi>B-00884883001732</basicUdiDi>
    <tradeName>00884883001732</tradeName>
    <deviceName>CEDIA Buprenorphine 50 ng/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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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:25.832Z</lastUpdated>
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    <basicUdiDi>B-00884883001725</basicUdiDi>
    <tradeName>00884883001725</tradeName>
    <deviceName>CEDIA Buprenorphine 20 ng/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>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:23.429Z</lastUpdated>
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    <udiDi>00884883001718</udiDi>
    <basicUdiDi>B-00884883001718</basicUdiDi>
    <tradeName>00884883001718</tradeName>
    <deviceName>CEDIA Buprenorphine 5 ng/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>100242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:21.824Z</lastUpdated>
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    <udiDi>00884883001701</udiDi>
    <basicUdiDi>B-00884883001701</basicUdiDi>
    <tradeName>00884883001701</tradeName>
    <deviceName>CEDIA Buprenorphine 0 ng/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>100241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:21.025Z</lastUpdated>
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    <udiDi>00884883001695</udiDi>
    <basicUdiDi>B-00884883001695</basicUdiDi>
    <tradeName>00884883001695</tradeName>
    <deviceName>CEDIA Buprenorphine 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>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:19.424Z</lastUpdated>
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    <udiDi>00884883001602</udiDi>
    <basicUdiDi>B-00884883001602</basicUdiDi>
    <tradeName>00884883001602</tradeName>
    <deviceName>CEDIA Buprenorphine 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>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:13.023Z</lastUpdated>
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    <udiDi>00884883001596</udiDi>
    <basicUdiDi>B-00884883001596</basicUdiDi>
    <tradeName>00884883001596</tradeName>
    <deviceName>CEDIA Phencyclidine (PCP) 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>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100172</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:10.645Z</lastUpdated>
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    <udiDi>00884883001558</udiDi>
    <basicUdiDi>B-00884883001558</basicUdiDi>
    <tradeName>00884883001558</tradeName>
    <deviceName>CEDIA Heroin Metabolite (6-AM) 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:08.224Z</lastUpdated>
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    <udiDi>00884883001541</udiDi>
    <basicUdiDi>B-00884883001541</basicUdiDi>
    <tradeName>00884883001541</tradeName>
    <deviceName>CEDIA Amphetamines/Ecstasy 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>W0102090101</emdnCode>
    <emdnDescription>AMPHETAMINES GROUP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:06.619Z</lastUpdated>
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    <udiDi>00884883001534</udiDi>
    <basicUdiDi>B-00884883001534</basicUdiDi>
    <tradeName>00884883001534</tradeName>
    <deviceName>CEDIA Amphetamines/Ecstasy 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>W0102090101</emdnCode>
    <emdnDescription>AMPHETAMINES GROUP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:04.222Z</lastUpdated>
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    <udiDi>00884883001527</udiDi>
    <basicUdiDi>B-00884883001527</basicUdiDi>
    <tradeName>00884883001527</tradeName>
    <deviceName>CEDIA Multi-Level THC 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>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:02.619Z</lastUpdated>
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    <udiDi>00884883001510</udiDi>
    <basicUdiDi>B-00884883001510</basicUdiDi>
    <tradeName>00884883001510</tradeName>
    <deviceName>CEDIA Opiate 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100098</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:01.842Z</lastUpdated>
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    <udiDi>00884883001503</udiDi>
    <basicUdiDi>B-00884883001503</basicUdiDi>
    <tradeName>00884883001503</tradeName>
    <deviceName>CEDIA Methadone 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:00.215Z</lastUpdated>
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    <udiDi>00884883001497</udiDi>
    <basicUdiDi>B-00884883001497</basicUdiDi>
    <tradeName>00884883001497</tradeName>
    <deviceName>CEDIA Cocaine 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>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100095</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:57.868Z</lastUpdated>
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    <udiDi>00884883001480</udiDi>
    <basicUdiDi>B-00884883001480</basicUdiDi>
    <tradeName>00884883001480</tradeName>
    <deviceName>CEDIA Benzodiazepines 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>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100094</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:56.215Z</lastUpdated>
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    <basicUdiDi>B-00884883001473</basicUdiDi>
    <tradeName>00884883001473</tradeName>
    <deviceName>CEDIA Barbiturate 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>W0102090103</emdnCode>
    <emdnDescription>BARBITURATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100093</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:55.414Z</lastUpdated>
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    <basicUdiDi>B-00884883001466</basicUdiDi>
    <tradeName>00884883001466</tradeName>
    <deviceName>CEDIA Multi-Level THC 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>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:53.819Z</lastUpdated>
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    <udiDi>00884883001459</udiDi>
    <basicUdiDi>B-00884883001459</basicUdiDi>
    <tradeName>00884883001459</tradeName>
    <deviceName>CEDIA DAU Opiate</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:51.417Z</lastUpdated>
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