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    <deviceName>CEDIA Phencyclidine (PCP) OFT Assay_LC</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>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:15.270Z</lastUpdated>
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    <basicUdiDi>B-00884883000704</basicUdiDi>
    <tradeName>00884883000704</tradeName>
    <deviceName>QMS® Lidocaine (LIDO) 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>
    <legislation>IVDD</legislation>
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    <emdnDescription>LIDOCAINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00884883000537</udiDi>
    <basicUdiDi>B-00884883000537</basicUdiDi>
    <tradeName>00884883000537</tradeName>
    <deviceName>QMS Everolimus 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>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:12.866Z</lastUpdated>
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    <basicUdiDi>B-00884883000438</basicUdiDi>
    <tradeName>00884883000438</tradeName>
    <deviceName>DRI Hydrocodone Assay</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>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:11.264Z</lastUpdated>
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    <udiDi>00884883000421</udiDi>
    <basicUdiDi>B-00884883000421</basicUdiDi>
    <tradeName>00884883000421</tradeName>
    <deviceName>DRI Hydrocodone 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>10019766</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:08.858Z</lastUpdated>
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    <udiDi>00884883000414</udiDi>
    <basicUdiDi>B-00884883000414</basicUdiDi>
    <tradeName>00884883000414</tradeName>
    <deviceName>DRI Hydrocodone Assay</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>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:07.260Z</lastUpdated>
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    <udiDi>00884883000407</udiDi>
    <basicUdiDi>B-00884883000407</basicUdiDi>
    <tradeName>00884883000407</tradeName>
    <deviceName>DRI Hydrocodone Calibrator 1000</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>10018082</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:06.455Z</lastUpdated>
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    <udiDi>00884883000391</udiDi>
    <basicUdiDi>B-00884883000391</basicUdiDi>
    <tradeName>00884883000391</tradeName>
    <deviceName>DRI Hydrocodone 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>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:04.855Z</lastUpdated>
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    <udiDi>00884883000384</udiDi>
    <basicUdiDi>B-00884883000384</basicUdiDi>
    <tradeName>00884883000384</tradeName>
    <deviceName>DRI Hydrocodone Calibrator 300</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>10018080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:02.457Z</lastUpdated>
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    <udiDi>00884883000377</udiDi>
    <basicUdiDi>B-00884883000377</basicUdiDi>
    <tradeName>00884883000377</tradeName>
    <deviceName>DRI Hydrocodone Calibrator 100</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>10018079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:00.855Z</lastUpdated>
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    <udiDi>00884883000360</udiDi>
    <basicUdiDi>B-00884883000360</basicUdiDi>
    <tradeName>00884883000360</tradeName>
    <deviceName>DRI Hydrocodone Assay Control Kit (2 x 10 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018149</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:00.059Z</lastUpdated>
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    <udiDi>00884883000254</udiDi>
    <basicUdiDi>B-00884883000254</basicUdiDi>
    <tradeName>00884883000254</tradeName>
    <deviceName>PCP OFT 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>10018605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:58.461Z</lastUpdated>
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  <row>
    <udiDi>00884883000247</udiDi>
    <basicUdiDi>B-00884883000247</basicUdiDi>
    <tradeName>00884883000247</tradeName>
    <deviceName>CEDIA Opiate OFT 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>10018600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:56.054Z</lastUpdated>
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  <row>
    <udiDi>00884883000230</udiDi>
    <basicUdiDi>B-00884883000230</basicUdiDi>
    <tradeName>00884883000230</tradeName>
    <deviceName>CEDIA Methamphetamine OFT 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>W0102090102</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018595</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:54.458Z</lastUpdated>
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    <udiDi>00884883000223</udiDi>
    <basicUdiDi>B-00884883000223</basicUdiDi>
    <tradeName>00884883000223</tradeName>
    <deviceName>CEDIA Cocaine OFT 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>10018590</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:53.654Z</lastUpdated>
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    <udiDi>00884883000216</udiDi>
    <basicUdiDi>B-00884883000216</basicUdiDi>
    <tradeName>00884883000216</tradeName>
    <deviceName>CEDIA Cannabinoids OFT 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>10018585</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:52.055Z</lastUpdated>
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    <udiDi>00884883000209</udiDi>
    <basicUdiDi>B-00884883000209</basicUdiDi>
    <tradeName>00884883000209</tradeName>
    <deviceName>CEDIA Amphetamine OFT 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>10018579</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:49.652Z</lastUpdated>
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    <udiDi>00845275000665</udiDi>
    <basicUdiDi>B-00845275000665</basicUdiDi>
    <tradeName>00845275000665</tradeName>
    <deviceName>Pacific Hemostasis APTT-XL</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100403, J100403</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:50.288Z</lastUpdated>
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    <deviceName>Pacific Hemostasis® APTT-XL</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100402, J100402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:46.276Z</lastUpdated>
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    <basicUdiDi>B-00845275000610</basicUdiDi>
    <tradeName>00845275000610</tradeName>
    <deviceName>Pacific Hemostasis High Fibrinogen Control Plasma</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100607, J100607</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:45.475Z</lastUpdated>
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