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    <tradeName>Dilution Solution</tradeName>
    <deviceName>Dilution Solution</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628515UDI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <basicUdiDi>88823411W01030402C006BJS</basicUdiDi>
    <tradeName>Concentrated Wash</tradeName>
    <deviceName>Concentrated Wash</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
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    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>88823411W01030403C004KKK</basicUdiDi>
    <tradeName>Streptavidin-PE</tradeName>
    <deviceName>Streptavidin-PE</deviceName>
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    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
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    <basicUdiDi>88823411W01030403C004LKM</basicUdiDi>
    <tradeName>Nuclease-Free Water</tradeName>
    <deviceName>Nuclease-Free Water</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>757003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:41.253Z</lastUpdated>
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    <udiDi>10888234400134</udiDi>
    <basicUdiDi>88823411W01030403C004IKF</basicUdiDi>
    <tradeName>LIFECODES Taq Polymerase</tradeName>
    <deviceName>LIFECODES Taq Polymerase</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:40.438Z</lastUpdated>
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    <udiDi>10888234100805</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 11 HLA Typing Kit, 24 test</tradeName>
    <deviceName>MIA FORA NGS MFlex HLA Typing Kit &amp; Software</deviceName>
    <manufacturerName>BioArray Solutions Ltd</manufacturerName>
    <manufacturerSrn>US-MF-000022068</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR-800-10534-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:39.671Z</lastUpdated>
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    <udiDi>10888234500421</udiDi>
    <basicUdiDi>88823411W0103020402C01DUK</basicUdiDi>
    <tradeName>PF4 Concentrated Wash</tradeName>
    <deviceName>PF4 Concentrated Wash</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:10:07.498Z</lastUpdated>
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    <basicUdiDi>88823411W0103020402C01CUH</basicUdiDi>
    <tradeName>Specimen Diluent</tradeName>
    <deviceName>Specimen Diluent</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:52.242Z</lastUpdated>
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    <udiDi>10888234400516</udiDi>
    <basicUdiDi>88823411W01030402C002HJS</basicUdiDi>
    <tradeName>LIFECODES Wash Buffer</tradeName>
    <deviceName>LIFECODES Wash Buffer</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:50.689Z</lastUpdated>
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    <udiDi>10888234002413</udiDi>
    <basicUdiDi>88823401W0103030305C000SN</basicUdiDi>
    <tradeName>Automated C3d plate</tradeName>
    <deviceName>Automated C3d Plate</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030305</emdnCode>
    <emdnDescription>MONOSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0066260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:13.804Z</lastUpdated>
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    <udiDi>10888234002390</udiDi>
    <basicUdiDi>88823401W0103030501C104SR</basicUdiDi>
    <tradeName>Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent</tradeName>
    <deviceName>Anti-k (Monoclonal) (IgG) Gamma-clone</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004817</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:12.201Z</lastUpdated>
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    <udiDi>10888234002338</udiDi>
    <basicUdiDi>88823401W0202030102A000QF</basicUdiDi>
    <tradeName>ECHO Lumena</tradeName>
    <deviceName>ECHO Lumena</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030102</emdnCode>
    <emdnDescription>AUTOMATED BLOOD GROUPING ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0086998</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:09.805Z</lastUpdated>
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    <tradeName>Gamma-clone Anti-Cw (Monoclonal) Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Cw (Monoclonal) Gamma-clone®</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030299</emdnCode>
    <emdnDescription>RHESUS TYPING ASSAYS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004819</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:08.200Z</lastUpdated>
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    <tradeName>Anti-Lea (Murine Monoclonal) Gamma-clone Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Lea (Murine Monoclonal) Gamma-clone</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004861</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:07.441Z</lastUpdated>
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    <tradeName>Anti-Leb (Murine Monoclonal) Gamma-clone Blood Grouping Reagent</tradeName>
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    <manufacturerName>Immucor, Inc.</manufacturerName>
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    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004864</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:05.817Z</lastUpdated>
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    <tradeName>Galileo Echo</tradeName>
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    <manufacturerName>Immucor, Inc.</manufacturerName>
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    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED BLOOD GROUPING ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0087000R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:50.559Z</lastUpdated>
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    <tradeName>Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone</tradeName>
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    <manufacturerName>Immucor, Inc.</manufacturerName>
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    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0409703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:48.922Z</lastUpdated>
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    <tradeName>CMT Plates</tradeName>
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    <manufacturerName>Immucor, Inc.</manufacturerName>
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    <emdnCode>W0202030185</emdnCode>
    <emdnDescription>BLOOD GROUPING ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0089000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <tradeName>DAT Positive Control Cell (1 x 10 mL)</tradeName>
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    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0066122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:46.525Z</lastUpdated>
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    <tradeName>Specimen Diluent</tradeName>
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    <manufacturerName>Immucor, Inc.</manufacturerName>
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    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0066053</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:44.142Z</lastUpdated>
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