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    <basicUdiDi>5051716TBRB</basicUdiDi>
    <tradeName>T-SPOT.TB</tradeName>
    <deviceName>T-SPOT.TB</deviceName>
    <manufacturerName>Oxford Immunotec Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004429</manufacturerSrn>
    <authorisedRepresentativeName>Wallac Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000044744</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB.300</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:06:09.716Z</lastUpdated>
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    <udiDi>03573026608576</udiDi>
    <basicUdiDi>357302BUDI000853U7</basicUdiDi>
    <tradeName>VIDAS® TB-IGRA</tradeName>
    <deviceName>VIDAS® TB-IGRA</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423111</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:58:00.125Z</lastUpdated>
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    <udiDi>D-KR-TB-IGRA-01050W7U</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01050W7U</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01050W</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:13.949Z</lastUpdated>
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    <udiDi>D-KR-TB-IGRA-01020C65</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01020C65</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01020C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:10.051Z</lastUpdated>
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    <udiDi>20850076346441</udiDi>
    <basicUdiDi>B-20850076346441</basicUdiDi>
    <tradeName>Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)</tradeName>
    <deviceName>Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCTBIG-401a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:03:33.457Z</lastUpdated>
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  <row>
    <udiDi>04053228015963</udiDi>
    <basicUdiDi>4053228RTBQFT0000000001W8</basicUdiDi>
    <tradeName>QFT-Plus Reference Lab Pack</tradeName>
    <deviceName>QuantiFERON-TB Gold Plus (QFT-Plus)</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622822</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:22:57.934Z</lastUpdated>
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    <udiDi>07613336228609</udiDi>
    <basicUdiDi>761333602954BP</basicUdiDi>
    <tradeName>Elecsys IGRA TB</tradeName>
    <deviceName>Elecsys IGRA TB</deviceName>
    <manufacturerName>Roche Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006260</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09989951190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:30.383Z</lastUpdated>
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    <udiDi>06973600799831</udiDi>
    <basicUdiDi>697360079019K4</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01050W</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:25.716Z</lastUpdated>
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    <udiDi>06973600799824</udiDi>
    <basicUdiDi>697360079019K4</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01020C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:24.525Z</lastUpdated>
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    <udiDi>06970301452638</udiDi>
    <basicUdiDi>B-06970301452638</basicUdiDi>
    <tradeName>06970301452638</tradeName>
    <deviceName>WANTAI TB-IGRA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WT-1196</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:29.506Z</lastUpdated>
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    <udiDi>06954414736991</udiDi>
    <basicUdiDi>695441473637JN</basicUdiDi>
    <tradeName>MAGICL TB-IGRA (CLIA)</tradeName>
    <deviceName>MAGICL TB-IGRA (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLIA3147A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:29:11.955Z</lastUpdated>
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    <udiDi>06954414736557</udiDi>
    <basicUdiDi>695441473637JN</basicUdiDi>
    <tradeName>MAGICL TB-IGRA (CLIA)</tradeName>
    <deviceName>MAGICL TB-IGRA (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLIA3147A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:29:05.922Z</lastUpdated>
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    <udiDi>06954414736373</udiDi>
    <basicUdiDi>695441473637JN</basicUdiDi>
    <tradeName>MAGICL TB-IGRA (CLIA)</tradeName>
    <deviceName>MAGICL TB-IGRA (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLIA3147A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:29:04.720Z</lastUpdated>
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    <udiDi>06954414736076</udiDi>
    <basicUdiDi>695441473637JN</basicUdiDi>
    <tradeName>MAGICL TB-IGRA (CLIA)</tradeName>
    <deviceName>MAGICL TB-IGRA (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLIA3147A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:29:03.531Z</lastUpdated>
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    <udiDi>06942028508936</udiDi>
    <basicUdiDi>B-06942028508936</basicUdiDi>
    <tradeName>Interferon-Gamma Release Assay for Mycobacterium tuberculosis Test Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Interferon-Gamma Release Assay for Mycobacterium tuberculosis Test Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DF1800</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:27.723Z</lastUpdated>
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    <udiDi>04053228022107</udiDi>
    <basicUdiDi>4053228RTBQFT0000000001W8</basicUdiDi>
    <tradeName>QFT-Plus 2 Plate Kit ELISA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:25:27.335Z</lastUpdated>
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