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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <tradeName>Diluent Rack, Set DA - DC</tradeName>
    <deviceName>Diluent Rack, Set DA - DC</deviceName>
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    <tradeName>Syringe, 250 µL PE, PSD4</tradeName>
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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <tradeName>Reagent Rack, Set RG - RM</tradeName>
    <deviceName>Reagent Rack, Set RG - RM</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>Reagent Rack, Set RA - RF</tradeName>
    <deviceName>Reagent Rack, Set RA - RF</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>HemosIL Protein S Activity</tradeName>
    <deviceName>HemosIL Protein S Activity</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020608</emdnCode>
    <emdnDescription>PROTEIN S ACTIVITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020302000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>HemosIL AcuStar HIT Controls</tradeName>
    <deviceName>HemosIL AcuStar HIT Controls</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:13.253Z</lastUpdated>
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    <tradeName>HemosIL AcuStar HIT-IgG(PF4-H)</tradeName>
    <deviceName>HemosIL AcuStar HIT-IgG(PF4-H)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:12.448Z</lastUpdated>
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    <tradeName>HemosIL Rinse Solution</tradeName>
    <deviceName>HemosIL Rinse Solution</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020302400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:06.842Z</lastUpdated>
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    <udiDi>08426950513735</udiDi>
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    <tradeName>HemosIL LA Positive Control</tradeName>
    <deviceName>HemosIL LA Positive Control</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020012500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:06.042Z</lastUpdated>
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    <tradeName>HemosIL LA Negative Control</tradeName>
    <deviceName>HemosIL LA Negative Control</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020012600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:05.240Z</lastUpdated>
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    <tradeName>HemosIL dRVVT Confirm</tradeName>
    <deviceName>HemosIL dRVVT Confirm</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:01.248Z</lastUpdated>
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    <tradeName>HemosIL dRVVT Screen</tradeName>
    <deviceName>HemosIL dRVVT Screen</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:00.438Z</lastUpdated>
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    <tradeName>Rotor Waste Container</tradeName>
    <deviceName>Rotor Waste Container</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00018110897</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:59.634Z</lastUpdated>
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    <tradeName>Liner, Waste Bucket, 10pk</tradeName>
    <deviceName>Liner, Waste Bucket, 10pk</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <tradeName>ACL AcuStar</tradeName>
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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
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    <reference>0009801000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>AcuStar Cuvettes</tradeName>
    <deviceName>AcuStar Cuvettes</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <tradeName>HemosIL AcuStar Triggers</tradeName>
    <deviceName>HemosIL AcuStar Triggers</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802201</reference>
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    <lastUpdated>2026-07-03T10:05:52.437Z</lastUpdated>
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    <tradeName>HemosIL AcuStar System Rinse</tradeName>
    <deviceName>HemosIL AcuStar System Rinse</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls</tradeName>
    <deviceName>HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802116</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:47.629Z</lastUpdated>
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