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    <tradeName>IDH1 R132H [IHC132]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3253AA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:51:03.457Z</lastUpdated>
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    <udiDi>00847627028860</udiDi>
    <basicUdiDi>B-00847627028860</basicUdiDi>
    <tradeName>IDH1 R132H [IHC132]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI3253T60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:51:03.399Z</lastUpdated>
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    <udiDi>00847627001825</udiDi>
    <basicUdiDi>B-00847627001825</basicUdiDi>
    <tradeName>IDO1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3210A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:51:01.539Z</lastUpdated>
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    <udiDi>00847627004789</udiDi>
    <basicUdiDi>B-00847627004789</basicUdiDi>
    <tradeName>CD4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3209AA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:50:49.245Z</lastUpdated>
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    <udiDi>00847627001832</udiDi>
    <basicUdiDi>B-00847627001832</basicUdiDi>
    <tradeName>IDO1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3210B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:27:31.588Z</lastUpdated>
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    <udiDi>00847627027603</udiDi>
    <basicUdiDi>B-00847627027603</basicUdiDi>
    <tradeName>IFNG [IFNG/3996R]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3266A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:27:29.020Z</lastUpdated>
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    <udiDi>00847627007520</udiDi>
    <basicUdiDi>B-00847627007520</basicUdiDi>
    <tradeName>IGF-1R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM414A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:27:28.786Z</lastUpdated>
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    <udiDi>00847627007537</udiDi>
    <basicUdiDi>B-00847627007537</basicUdiDi>
    <tradeName>IGF-1R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM414C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:27:19.556Z</lastUpdated>
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    <udiDi>00847627003003</udiDi>
    <basicUdiDi>B-00847627003003</basicUdiDi>
    <tradeName>IgG4 (M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3115A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:27:17.148Z</lastUpdated>
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    <udiDi>00847627003010</udiDi>
    <basicUdiDi>B-00847627003010</basicUdiDi>
    <tradeName>IgG4 (M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3115B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:27:04.313Z</lastUpdated>
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    <udiDi>00847627003287</udiDi>
    <basicUdiDi>B-00847627003287</basicUdiDi>
    <tradeName>CD4 [4B12]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3148A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:49.523Z</lastUpdated>
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    <udiDi>00847627003294</udiDi>
    <basicUdiDi>B-00847627003294</basicUdiDi>
    <tradeName>CD4 [4B12]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3148C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:49.161Z</lastUpdated>
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    <udiDi>00847627004208</udiDi>
    <basicUdiDi>B-00847627004208</basicUdiDi>
    <tradeName>IgG4 (M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3115AA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:49.018Z</lastUpdated>
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    <udiDi>00847627004352</udiDi>
    <basicUdiDi>B-00847627004352</basicUdiDi>
    <tradeName>CD4 [4B12]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3148AA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:49.000Z</lastUpdated>
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    <udiDi>00847627011305</udiDi>
    <basicUdiDi>B-00847627011305</basicUdiDi>
    <tradeName>Inhibin, Alpha</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM171AA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:48.948Z</lastUpdated>
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  <row>
    <udiDi>00847627004437</udiDi>
    <basicUdiDi>B-00847627004437</basicUdiDi>
    <tradeName>CD4 + CD8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3157DSAA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:48.373Z</lastUpdated>
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    <udiDi>00847627029782</udiDi>
    <basicUdiDi>B-00847627029782</basicUdiDi>
    <tradeName>Leukocyte Common Antigen (LCA) Cocktail</tradeName>
    <deviceName>Leukocyte Common Antigen (LCA) Cocktail</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI016T60</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:29.762Z</lastUpdated>
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    <udiDi>00847627029126</udiDi>
    <basicUdiDi>B-00847627029126</basicUdiDi>
    <tradeName>Ki-67</tradeName>
    <deviceName>Ki-67</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI325T60</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:24.954Z</lastUpdated>
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    <udiDi>00847627029102</udiDi>
    <basicUdiDi>B-00847627029102</basicUdiDi>
    <tradeName>Ki-67  [MIB-1]</tradeName>
    <deviceName>Ki-67  [MIB-1]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080204</emdnCode>
    <emdnDescription>PROLIFERATION MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI3156T60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:24.166Z</lastUpdated>
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    <udiDi>00847627029010</udiDi>
    <basicUdiDi>B-00847627029010</basicUdiDi>
    <tradeName>Uroplakin II</tradeName>
    <deviceName>Uroplakin II [BC21] 25 ml</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>AVI3051KG25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:23.356Z</lastUpdated>
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