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    <tradeName>LeukoStrat® NPM1 Mutation Assay Megakit - ABI Fluorescence Detection</tradeName>
    <deviceName>NPM1 Mutation Assay for ABI Fluorescence Detection</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-416-0001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:13:18.814Z</lastUpdated>
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    <udiDi>00850052003630</udiDi>
    <basicUdiDi>B-00850052003630</basicUdiDi>
    <tradeName>T Cell Receptor Gamma Gene Rearrangement</tradeName>
    <deviceName>T Cell Receptor Gamma Gene Rearrangement Assay 2.0 Megakit</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-207-0111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:20.918Z</lastUpdated>
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    <udiDi>00850052003623</udiDi>
    <basicUdiDi>B-00850052003623</basicUdiDi>
    <tradeName>T Cell Receptor Gamma Gene Rearrangement</tradeName>
    <deviceName>T Cell Receptor Gamma Gene Rearrangement Assay 2.0</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-207-0101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:16.939Z</lastUpdated>
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    <udiDi>00850052003159</udiDi>
    <basicUdiDi>B-00850052003159</basicUdiDi>
    <tradeName>IGH Gene Clonality Assay</tradeName>
    <deviceName>IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-101-0081</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:16.122Z</lastUpdated>
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    <udiDi>00850052003142</udiDi>
    <basicUdiDi>B-00850052003142</basicUdiDi>
    <tradeName>IGH Gene Clonality Assay</tradeName>
    <deviceName>IGH Gene Clonality Assay for ABI Fluorescence Detection</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-101-0061</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:15.325Z</lastUpdated>
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    <udiDi>00810022732595</udiDi>
    <basicUdiDi>081002273K41204314J</basicUdiDi>
    <tradeName>LeukoStrat CDx FLT3 Mutation Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T13:15:28.014Z</lastUpdated>
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    <udiDi>00810022732557</udiDi>
    <basicUdiDi>081002273K41204314J</basicUdiDi>
    <tradeName>LeukoStrat CDx FLT3 Mutation Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T13:15:26.871Z</lastUpdated>
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    <udiDi>00810022732502</udiDi>
    <basicUdiDi>08100227391010101P9</basicUdiDi>
    <tradeName>IdentiClone® Dx IGH Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T13:15:25.700Z</lastUpdated>
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