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    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
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    <tradeName>Tyrosinase; Clone T311 (Concentrate) 1 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <tradeName>MART-1; Clones M2-7C10 &amp; M2-9E3 (Ready-To-Use) 7 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
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    <tradeName>MART-1; Clones M2-7C10 &amp; M2-9E3 (Ready-To-Use) 25 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
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    <reference>A00133-0025</reference>
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    <udiDi>00810108712046</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>MART-1; Clones M2-7C10 &amp; M2-9E3 (Concentrate) 1 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00133-C</reference>
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    <lastUpdated>2026-07-08T06:58:44.887Z</lastUpdated>
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    <udiDi>00810108712053</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Melanoma; Pan (Ready-To-Use) 7 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00134-0007</reference>
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    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Melanoma; Pan (Ready-To-Use) 25 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00134-0025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.834Z</lastUpdated>
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    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Melanoma; Pan (Concentrate) 1 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00134-C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.802Z</lastUpdated>
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    <udiDi>00810108712084</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen, Pan (CEA); Clone COL-1 (Ready-To-Use) 7 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00135-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.770Z</lastUpdated>
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    <udiDi>00810108712091</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen, Pan (CEA); Clone COL-1 (Ready-To-Use) 25 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00135-0025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.736Z</lastUpdated>
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    <udiDi>00810108712107</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen, Pan (CEA); Clone COL-1 (Concentrate) 1 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00135-C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.721Z</lastUpdated>
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    <udiDi>00810108712114</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Cytokeratin 8; Clone K8/383 (Ready-To-Use) 7 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00136-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.702Z</lastUpdated>
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    <udiDi>00810108712121</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Cytokeratin 8; Clone K8/383 (Ready-To-Use) 25 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00136-0025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.675Z</lastUpdated>
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    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Cytokeratin 8; Clone K8/383 (Concentrate) 1 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00136-C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.649Z</lastUpdated>
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    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Cytokeratin 5,6 Cocktail; Clones EP42 &amp; EP67 (Ready-To-Use) 7 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00141-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
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    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
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    <reference>A00142-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
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    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00144-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:44.496Z</lastUpdated>
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